check_circleStudy Completed

Moderate Risk of CVD

A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease

Trial purpose

The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.

Key Participants Requirements

Sex

Both

Age

55 - N/A
  • - Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors:
     -- Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL; as measured at screening) irrespective of current treatment
     -- Current smoking: defined as any cigarette smoking in the past 12 months
     -- Low HDL cholesterol (HDL<40 mg/dL; as measured at screening)
     -- Elevated blood pressure (SBP>140 mmHg; as measured at screening)
     -- Currently on any medication to treat high blood pressure
     -- Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
    - Females aged 60 and above with 3 or more risk factors. Female Risk Factors:
     -- Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL; as measured at screening) irrespective of current treatment
     -- Current smoking: defined as any cigarette smoking in the past 12 months
     -- Low HDL cholesterol (HDL<40 mg/dL; as measured at screening)
     -- Elevated blood pressure (SBP>140 mmHg; as measured at screening)
     -- Currently on any medication to treat high blood pressure
     -- Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
    - An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial
  • - History of a documented vascular event, such as MI, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or vascular intervention
    - Patients who are at higher than moderate risk on the basis of their diabetes status, other factors known to the investigator, or the currently used national risk score
    - Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid
    - Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders
    - Active diagnosed and documented reflux esophagitis
    - Patients presenting with any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
    - Lactating women or women of childbearing potential
    - Severe liver disease or damage based on the clinical judgment of the investigator
    - Severe renal disease or damage based on the clinical judgement of the investigator
    - A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician
    - A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDS
    - Chronic, frequent (> 5 days/month) use of NSAIDs (including aspirin, or aspirin containing products), COX-2 inhibitors or metamizole
    - Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit
    - Current use of an anticoagulant medication
    - Sitting systolic blood pressure greater than 170 mmHg

Trial summary

Enrollment Goal
12546
Trial Dates
July 2007 - November 2016
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Arnsberg, 59757, Germany
Completed
Apolda, 99510, Germany
Completed
Magdeburg, 39104, Germany
Completed
Bergkamen, 59192, Germany
Withdrawn
Bergisch Gladbach, 51467, Germany
Withdrawn
Düsseldorf, 40477, Germany
Withdrawn
Worpswede, 27726, Germany
Completed
Bad Lippspringe, 33175, Germany
Completed
Nassau, 56377, Germany
Completed
Winsen, 21423, Germany
Completed
Deggingen, 73326, Germany
Completed
Köln, 51069, Germany
Completed
Gransee, 16775, Germany
Completed
Viersen, 41751, Germany
Withdrawn
Rodgau, 63110, Germany
Completed
Wetter, 35083, Germany
Completed
Lienen, 49536, Germany
Completed
Bad Salzuflen, 32105, Germany
Withdrawn
Otterbach, 67731, Germany
Completed
Stuhr, 28816, Germany
Completed
Arzberg, 95659, Germany
Completed
Frankfurt, 60599, Germany
Completed
Bad Bramstedt, 24576, Germany
Completed
Löhne, 32584, Germany
Withdrawn
Düsseldorf, 40593, Germany
Withdrawn
Schwaig, 90571, Germany
Withdrawn
Freiburg, 79110, Germany
Completed
Hamm, 59069, Germany
Withdrawn
Laage, 18299, Germany
Completed
Essen, 45136, Germany
Completed
Wardenburg, 26203, Germany
Completed
Lippetal, 59510, Germany
Withdrawn
Heilbronn, 74072, Germany
Completed
Netphen, 57250, Germany
Completed
Dortmund, 44328, Germany
Completed
Weinheim, 69469, Germany
Completed
Speyer, 67346, Germany
Completed
Hanau, 63450, Germany
Completed
Aachen, 52074, Germany
Withdrawn
Ense, 59469, Germany
Completed
Marl, 45770, Germany
Completed
Berlin, 10407, Germany
Completed
Wetter, 58300, Germany
Withdrawn
Leipzig, 04177, Germany
Completed
Langenfeld, 40764, Germany
Completed
Marl, 45770, Germany
Withdrawn
Offenbach, 63067, Germany
Withdrawn
Grevenbroich, 41515, Germany
Completed
Künzing, 94550, Germany
Withdrawn
Landshut, 84032, Germany
Completed
Aachen, 52080, Germany
Withdrawn
Leverkusen, 51373, Germany
Withdrawn
Frankfurt, 60323, Germany
Completed
Kelkheim, 65779, Germany
Completed
Berlin, 13057, Germany
Completed
Essen, 45355, Germany
Withdrawn
Oberursel, 61440, Germany
Completed
Potsdam, 14778, Germany
Withdrawn
Offenbach, 63073, Germany
Completed
Dortmund, 44139, Germany
Completed
Leipzig, 04249, Germany
Completed
Porta Westfalica, 32457, Germany
Withdrawn
Gärtringen, 71116, Germany
Completed
Hamburg, 22143, Germany
Completed
Spalt, 91174, Germany
Withdrawn
Heilbronn, 74072, Germany
Withdrawn
Lütjenburg, 24321, Germany
Completed
Welver, 59514, Germany
Completed
Stockach, 78333, Germany
Completed
Berlin, 10249, Germany
Withdrawn
Allmendingen, 89604, Germany
Completed
Dossenheim, 69221, Germany
Withdrawn
Heidelberg, 69129, Germany
Withdrawn
Rees, 46459, Germany
Completed
Bergrheinfeld, 97493, Germany
Completed
Weyhe, 28844, Germany
Completed
Greven, 48268, Germany
Completed
Hamburg, 22299, Germany
Completed
Bad Sassendorf, 59505, Germany
Completed
Hünxe, 46569, Germany
Completed
Reinfeld, 23858, Germany
Completed
Remscheid, 42897, Germany
Completed
Blankenhain, 99444, Germany
Completed
Bad Salzuflen, 32108, Germany
Completed
Sinzheim, 76547, Germany
Completed
Graben-Neudorf, 76676, Germany
Completed
Benningen, 71726, Germany
Completed
Heilbronn, 74080, Germany
Completed
Trossingen, 78647, Germany
Completed
Schwetzingen, 68723, Germany
Completed
Schrobenhausen, 86529, Germany
Completed
Ursensollen, 92289, Germany
Completed
Sulzbach-Rosenberg, 92237, Germany
Completed
Berlin, 13467, Germany
Completed
Ketzin, 14669, Germany
Withdrawn
Frankfurt, 60529, Germany
Completed
Horneburg, 21640, Germany
Completed
Bockenem, 31167, Germany
Completed
Beucha, 04824, Germany
Withdrawn
Dresden, 01219, Germany
Completed
Oberwiesenthal, 09484, Germany
Completed
Halle, 06124, Germany
Completed
Ludwigsburg, 71640, Germany
Completed
Gars, 83536, Germany
Completed
Strasskirchen, 94342, Germany
Completed
Ursensollen, 92289, Germany
Completed
München, 80336, Germany
Completed
Cottbus, 03046, Germany
Completed
Rotenburg, 36199, Germany
Completed
Jühnde, 37127, Germany
Completed
Braunschweig, 38100, Germany
Completed
Essen, 45130, Germany
Withdrawn
Köln, 51065, Germany
Withdrawn
Neuss, 41468, Germany
Completed
Essen, 45359, Germany
Completed
Ludwigshafen, 67063, Germany
Withdrawn
Norderstedt, 22844, Germany
Completed
Bochum, 44797, Germany
Completed
Marl, 45770, Germany
Completed
Dortmund, 44339, Germany
Completed
Freudenberg, 57258, Germany
Withdrawn
Mainz, 55128, Germany
Completed
Berlin, 13405, Germany
Completed
Frankfurt, 65929, Germany
Withdrawn
Berlin, 14169, Germany
Completed
Riesa, 01587, Germany
Completed
Dresden, 01127, Germany
Completed
Rhaunen, 55624, Germany
Completed
Essen, 45276, Germany
Completed
Papenburg, 26871, Germany
Completed
Delitzsch, 04509, Germany
Completed
Mainz, 55116, Germany
Completed
Dresden, 01069, Germany
Completed
Meißen, 01662, Germany
Completed
Grimma, 04668, Germany
Completed
Borna, 04552, Germany
Withdrawn
Weimar, 99423, Germany
Completed
Marl, 45770, Germany
Completed
Münster, 48167, Germany
Completed
Berlin, 13055, Germany
Completed
Mainz, 55127, Germany
Completed
Leipzig, 04103, Germany
Completed
Hamburg, 22041, Germany
Withdrawn
Berlin, 10437, Germany
Completed
Hockenheim, 68766, Germany
Completed
Kallstadt, 67169, Germany
Completed
Oberaurach, 97514, Germany
Completed
Sand am Main, 97522, Germany
Completed
Loxstedt, 27612, Germany
Completed
Berlin, 12099, Germany
Completed
Stuttgart, 70378, Germany
Completed
Siegen, 57072, Germany
Completed
Siegen, 57072, Germany
Completed
Witten, 58455, Germany
Withdrawn
Wilhelmshaven, 26384, Germany
Completed
Markkleeberg, 04416, Germany
Completed
Kamp-Lintfort, 47475, Germany
Completed
High Valleyfield, KY12 8SJ, United Kingdom
Completed
Saltash, PL12 6DL, United Kingdom
Completed
Barry, CF63 4HP, United Kingdom
Completed
Penzance, TR19 7HX, United Kingdom
Completed
Hamburg, 22335, Germany
Completed
Leipzig, 04103, Germany
Completed
Dinkelsbühl, 91550, Germany
Completed
Elsterwerda, 04910, Germany
Completed
Wermsdorf, 04779, Germany
Completed
Dresden, 01277, Germany
Completed
Berlin, 14050, Germany
Completed
Duisburg, 47199, Germany
Completed
Krefeld, 47798, Germany
Completed
Bitterfeld, 06749, Germany
Completed
Hamburg, 22177, Germany
Completed
Hohenau, 94545, Germany
Completed
Krefeld, 47798, Germany
Withdrawn
Schwerin, 19055, Germany
Withdrawn
Berlin, 10789, Germany
Completed
Boscastle, PL35 0BG, United Kingdom
Completed
Ely, CB7 5SQ, United Kingdom
Completed
Sheffield, S7 2DW, United Kingdom
Completed
Motherwell, ML1 3JX, United Kingdom
Completed
St Austell, PL26 7RL, United Kingdom
Completed
Ely, CB7 4HF, United Kingdom
Completed
Slough, SL1 1TT, United Kingdom
Completed
Cardiff, CF5 4AD, United Kingdom
Completed
Leeds, LS25 1AN, United Kingdom
Withdrawn
Dundee, DD1 5LA, United Kingdom
Completed
Peterborough, PE7 3JL, United Kingdom
Completed
Hamilton, ML3 ODR, United Kingdom
Completed
Darlington, DL2 1AA, United Kingdom
Completed
Thedinghausen, 27321, Germany
Completed
Nienburg, 31582, Germany
Withdrawn
Viersen, 41747, Germany
Completed
Ettlingen, 78275, Germany
Completed
Northeim, 37154, Germany
Completed
Aurich, 26603, Germany
Completed
Rehburg-Loccum, 31547, Germany
Completed
Daaden, 57567, Germany
Completed
Riede, 27339, Germany
Completed
Riesa, 01587, Germany
Withdrawn
Dresden, 01277, Germany
Completed
Chipping Norton, OX75FA, United Kingdom
Completed
Bath, BA11 2FH, United Kingdom
Completed
Crawley, RH10 7DX, United Kingdom
Completed
Letchworth, SG6 4TS, United Kingdom
Withdrawn
Ruislip, HA4 7AE, United Kingdom
Completed
Wells-Next-The-Sea, NR23 1JP, United Kingdom
Completed
Wishaw, ML2 7BQ, United Kingdom
Completed
Sandbach, CW11 1EQ, United Kingdom
Completed
Leeds, LS25 7AB, United Kingdom
Completed
Peterborough, PE8 6PL, United Kingdom
Completed
Wymondham, NR18 0RF, United Kingdom
Completed
Bath, BA2 4BY, United Kingdom
Completed
Penzance, TR18 4EL, United Kingdom
Completed
Wellingborough, NN8 4RW, United Kingdom
Completed
Plymouth, PL6 7TH, United Kingdom
Completed
Bradford-on-Avon, BA15 1DQ, United Kingdom
Withdrawn
Bracknell, RG12 7WW, United Kingdom
Completed
Fowey, PL23 1DT, United Kingdom
Completed
Penzance, TR18 4JH, United Kingdom
Completed
Chippenham, SN14 6GT, United Kingdom
Completed
Bath, BA2 4JT, United Kingdom
Completed
Crawley, RH10 1LL, United Kingdom
Completed
Bath, BA2 3HT, United Kingdom
Completed
Bath, BA2 3HT, United Kingdom
Completed
Chippenham, SN15 2SB, United Kingdom
Completed
Westbury, BA13 3FQ, United Kingdom
Completed
Annan, DG12 6BG, United Kingdom
Completed
New Stevenson, ML1 4LT, United Kingdom
Completed
Darlington, DL3 7JR, United Kingdom
Completed
Bangor, BT19 1PP, United Kingdom
Completed
Antrim, BT36 4PP, United Kingdom
Completed
Antrim, BT37 9QN, United Kingdom
Completed
Glasgow, G21 1TR, United Kingdom
Completed
Aberdeen, AB25 2ZD, United Kingdom
Completed
Chestfield, CT5 3QU, United Kingdom
Completed
Canterbury, CT1 3HX, United Kingdom
Completed
Chesterfield, S40 4AA, United Kingdom
Completed
Eccles, S35 9XQ, United Kingdom
Completed
Wishaw, ML2 7BQ, United Kingdom
Completed
Glasgow, G67 1BJ, United Kingdom
Completed
Glasgow, G45 9AW, United Kingdom
Completed
Glasgow, G20 0XA, United Kingdom
Withdrawn
Ipswich, IP2 0QQ, United Kingdom
Completed
London, SW12 8EU, United Kingdom
Completed
Trowbridge, BA14 9AR, United Kingdom
Completed
Doncaster, DN1 2ET, United Kingdom
Completed
Coventry, CV7 8LA, United Kingdom
Completed
Blantyre, G72 0BS, United Kingdom
Completed
Leigh-on-Sea, SS9 2SQ, United Kingdom
Completed
Hamilton, ML3 8AA, United Kingdom
Completed
Coatbridge, ML5 3AP, United Kingdom
Completed
Chapelhall, ML6 8SR, United Kingdom
Completed
Worcester Park, KT4 7BX, United Kingdom
Completed
Hinckley, LE10 2SE, United Kingdom
Completed
Hitchin, SG4 9TH, United Kingdom
Completed
East Horsley, KT24 6QT, United Kingdom
Completed
Blackpool, FY3 7EN, United Kingdom
Completed
Antrim, BT38 9TG, United Kingdom
Completed
Hamilton, ML3 7EN, United Kingdom
Completed
Addlestone, KT15 2BH, United Kingdom
Completed
Belfast, United Kingdom
Completed
Belfast, BT12 5LT, United Kingdom
Completed
Belfast, BT12 5EY, United Kingdom
Completed
Coventry, CV9 1EU, United Kingdom
Completed
Radstock, BA3 2UH, United Kingdom
Completed
Luton, LU2 9SB, United Kingdom
Completed
Bury St. Edmunds, IP32 7EW, United Kingdom
Completed
Bolton, BL3 6TL, United Kingdom
Completed
Dronfield, S18 8QY, United Kingdom
Completed
Leeds, LS26 8SZ, United Kingdom
Completed
Bishop Auckland, DL14 6AB, United Kingdom
Completed
Stowmarket, IP14 1NL, United Kingdom
Completed
Inverness, IV2 4AG, United Kingdom
Completed
Irvine, KA12 0AY, United Kingdom
Completed
Blackpool, FY4 3AD, United Kingdom
Completed
Peterborough, PE2 5GP, United Kingdom
Completed
Antrim, BT41 3AE, United Kingdom
Completed
Tyrone, BT80 8BG, United Kingdom
Completed
Darlington, DL3 8SQ, United Kingdom
Completed
Whitstable, CT5 3SE, United Kingdom
Completed
Rugby, CV21 3SP, United Kingdom
Completed
Doncaster, DN1 2EU, United Kingdom
Completed
Ipswich, IP4 2PU, United Kingdom
Completed
Leeds, LS10 3NB, United Kingdom
Completed
Newcastle Upon Tyne, NE15 6TQ, United Kingdom
Completed
Coatrbridge, ML5 3BJ, United Kingdom
Completed
Carstairs, ML11 8QD, United Kingdom
Completed
Thornhill, DG3 5AA, United Kingdom
Completed
Bolton, BL5 3UB, United Kingdom
Completed
Witley Bay, NE26 1NA, United Kingdom
Completed
Craigavon, BT67 0LQ, United Kingdom
Completed
Newtonabbey, BT37 9QU, United Kingdom
Withdrawn
Downingtown, 19335, United States
Completed
Belvidere, 07823, United States
Completed
Taylors, 29687, United States
Withdrawn
Flemington, 08822, United States
Completed
Atlanta, 30318, United States
Completed
Bury St Edmonds, IP30 9QU, United Kingdom
Completed
Tiptree, CO5 0HB, United Kingdom
Completed
Bellshill, ML4 1PS, United Kingdom
Completed
Brighton, BN2 1ES, United Kingdom
Completed
Glasgow, G5 0BQ, United Kingdom
Completed
Johnstone, PA5 8EY, United Kingdom
Completed
Airedire, ML66DB, United Kingdom
Completed
Paisley, United Kingdom
Completed
Letchworth, SG6 4UB, United Kingdom
Completed
Corsham, SN3 9DL, United Kingdom
Completed
Belfast, BT5 7BP, United Kingdom
Completed
Glasgow, G52 3QN, United Kingdom
Completed
Coventry, CV6 4DD, United Kingdom
Completed
Manchester, M13 9WL, United Kingdom
Completed
Belfast, BT13 3BW, United Kingdom
Completed
Tallahassee Memorial FamilyQuincy, 32351, United States
Completed
Marianna, 32446-2120, United States
Withdrawn
Toledo, 43617, United States
Withdrawn
Baltimore, 21204, United States
Completed
Tucson, 85712, United States
Completed
Daingerfield, 75638, United States
Withdrawn
Garden Grove, 92843, United States
Withdrawn
Trenton, 08618, United States
Completed
Carlisle, 45005-3320, United States
Withdrawn
Erie, 16504, United States
Completed
Clifton, 07013, United States
Withdrawn
Bridgewater, 08807, United States
Completed
Huntington Park, 90255, United States
Completed
Medical Research Centers of South Florida, Inc.Hollywood, 33021, United States
Completed
Broken Bow, 68822, United States
Completed
Carryduff, BT8 8HR, United Kingdom
Completed
Belfast, BT1 2JR, United Kingdom
Completed
Belfast, BT15 2GE, United Kingdom
Completed
Ballymena, BT43 6JD, United Kingdom
Completed
Ballymena, BT42 4JP, United Kingdom
Completed
Crumlin, BT29 4LP, United Kingdom
Completed
Watford, WD25 7NL, United Kingdom
Completed
Bath, BA1 2SR, United Kingdom
Completed
Blantyre, G72 0BS, United Kingdom
Completed
Dundee, DD19SY, United Kingdom
Completed
Hadleigh, IP7 5DN, United Kingdom
Completed
Bury St. Edmunds, IP31 2HD, United Kingdom
Completed
Leeds, LS15 9JH, United Kingdom
Completed
Leeds, LS25 1HB, United Kingdom
Completed
Leeds, LS118BS, United Kingdom
Withdrawn
Merritt Island, 32953, United States
Completed
Vernon Hills, 60061, United States
Completed
San Marcos, 78666, United States
Withdrawn
Salt Lake City, 84124, United States
Withdrawn
Milwaukee, 53218, United States
Completed
Montgomery, 45242, United States
Completed
Office of Dr.Larry Levinson, DOHollywood, 33021, United States
Completed
Jersey City, 07306, United States
Completed
Greensboro, 27401, United States
Completed
Scottsdale, 85260, United States
Completed
Rancho Cucamonga, 91730, United States
Completed
Rolling Hills Estates, 90274, United States
Completed
Medical Research TrustBoynton Beach, 33426, United States
Completed
Birmingham, 39294, United States
Completed
Stratford, 08084, United States
Completed
Leeds, LS9 9EF, United Kingdom
Completed
Forth, ML1 8AJ, United Kingdom
Completed
Lockerbie, D11 2BJ, United Kingdom
Completed
Crossgar, BT30 9JU, United Kingdom
Completed
Belfast, BT8 6GR, United Kingdom
Completed
Kissimmee, 34741, United States
Withdrawn
Zionsville, 18092, United States
Completed
Port Gibson, 39150, United States
Withdrawn
Columbus, 31901, United States
Completed
Prince Frederick, 20678, United States
Completed
Sugar Land, 77478, United States
Withdrawn
Monmouth Junction, 08852, United States
Withdrawn
Hallandale, 33009, United States
Withdrawn
Spring, 77379, United States
Completed
Gainesville, 32601, United States
Completed
Hialeah, 33016, United States
Withdrawn
Miami, 33155, United States
Withdrawn
Plantation, 33324, United States
Completed
Tampa, 33614, United States
Withdrawn
Chicago, 60610, United States
Completed
Lockport, 60491, United States
Withdrawn
Morton, 61550, United States
Completed
Evansville, 47713, United States
Completed
Lebanon, 40033, United States
Withdrawn
Sterling Heights, 48310, United States
Withdrawn
Spring, 77386, United States
Completed
Merit Medical Group, Inc.Richlands, 24641-2067, United States
Withdrawn
Humble, 77338, United States
Withdrawn
Phoenixville, 19460, United States
Completed
Phoenix, 85051, United States
Completed
Duncansville, 16635, United States
Completed
Omaha, 68116-2004, United States
Completed
Helping Hands Clinical TrialsSanta Ana, 92704, United States
Completed
Lawrenceville, 08648, United States
Withdrawn
Phoenix, 85016, United States
Withdrawn
Williamsville, 14221, United States
Withdrawn
West Jordan, 84088, United States
Completed
Graysville, 35073, United States
Withdrawn
Warwick, 02888, United States
Withdrawn
El Cajon, 92019, United States
Completed
Hot Springs, 71913-4457, United States
Withdrawn
Glendora, 91740, United States
Completed
Rockwall, 75032, United States
Completed
Perrysburg, 43551, United States
Withdrawn
Bensalem, 19020, United States
Completed
Marion, 43302, United States
Withdrawn
Corpus Christi, 78411, United States
Withdrawn
Salt Lake City, 84107, United States
Withdrawn
Feasterville Trevose, 19053, United States
Withdrawn
Tampa, 33624, United States
Completed
Raleigh, 27609, United States
Withdrawn
Scarborough, 04074, United States
Completed
Los Angeles, 90025, United States
Withdrawn
Huntington Beach, 92647, United States
Withdrawn
San Francisco, 94117, United States
Withdrawn
San Leandro, 94578, United States
Withdrawn
Tulare, 93274, United States
Withdrawn
Altamonte Springs, 32714, United States
Withdrawn
Davie, 33314, United States
Completed
Pell City, 35125, United States
Completed
Hialeah, 33016, United States
Completed
Largo, 33770, United States
Withdrawn
Marianna, 32446, United States
Withdrawn
Miami, 33101, United States
Withdrawn
Port Richey, 34668, United States
Withdrawn
Chicago, 60631, United States
Completed
Chicago, 60628, United States
Withdrawn
Holden, 01520, United States
Withdrawn
Torrance, 90503, United States
Withdrawn
Bend, 97701, United States
Completed
Chicago, 60631-1958, United States
Withdrawn
Des Moines, 50316, United States
Completed
Newark, 19702, United States
Withdrawn
Little Rock, 72202, United States
Withdrawn
Houston, 77090, United States
Completed
Doylestown, 18901, United States
Withdrawn
Phoenix, 85029, United States
Withdrawn
Houston, 77088, United States
Withdrawn
New York, 10016, United States
Withdrawn
Kingwood, 77339, United States
Withdrawn
Shreveport, 71106, United States
Completed
San Antonio, 78205-1116, United States
Withdrawn
Peoria, 61406, United States
Completed
Fort Wayne, 46804, United States
Withdrawn
Kokomo, 46902, United States
Completed
Bridgman, 49106, United States
Completed
Interlochen, 49643-9264, United States
Completed
Cadillac, 49601, United States
Completed
Florissant, 63031, United States
Completed
Stephenville, 76401, United States
Completed
Honaker, 24260, United States
Withdrawn
Philadelphia, 19143, United States
Withdrawn
Simpsonville, 29681, United States
Withdrawn
Rogersville, 37857, United States
Withdrawn
Ashtabula, 44004, United States
Withdrawn
Glendora, 08029, United States
Withdrawn
Benzonia, 49616, United States
Completed
Burlington, 27215, United States
Completed
Cherry Hill, 08084, United States
Withdrawn
Plantation, 33324, United States
Completed
Manati, 00674, United States
Completed
Guaynabo, 00968, United States
Completed
Trujilo Alto, 00976, United States
Completed
Skierniewice, 96-100, Poland
Completed
Poznan, 60-539, Poland
Completed
Sobotka, Poland
Completed
Lublin, 20-258, Poland
Completed
Lodz, Poland
Completed
Chrzanow, Poland
Completed
Wloclawek, Poland
Completed
Linia, 84-223, Poland
Completed
Katowice, 40-752, Poland
Completed
Lublin, Poland
Completed
Linden, 07036, United States
Completed
PharmaTrials, Inc.Perth Amboy, 08861, United States
Withdrawn
Buckingham, 18912, United States
Withdrawn
Dauphin, 17018, United States
Withdrawn
Arlington, 76012, United States
Withdrawn
Dallas, 75224, United States
Withdrawn
Greenville, 29601, United States
Withdrawn
Lindale, 75771, United States
Completed
McKinney, 75069, United States
Completed
Panama City, 32401, United States
Completed
Columbus, 28722, United States
Completed
Troy, 48085, United States
Completed
Krakow, 31-567, Poland
Completed
Radom, 26-600, Poland
Completed
Lancut, Poland
Withdrawn
Rzeszow, Poland
Completed
Olkusz, Poland
Completed
Gdansk, 80-286, Poland
Completed
Skierniewice, Poland
Completed
Lodz, Poland
Withdrawn
Wroclaw, Poland
Completed
Katowice, 40-226, Poland
Completed
Gliwice, 44-109, Poland
Completed
Bialystok, 15-183, Poland
Completed
Krakow, 31-637, Poland
Completed
Warszawa, 02-796, Poland
Completed
Wroclaw, 51-112, Poland
Completed
Gdynia, 81-317, Poland
Completed
Sellersville, 18960, United States
Withdrawn
Delaware, 43105, United States
Withdrawn
Voorhees, 08043, United States
Withdrawn
Tomball, 77375, United States
Withdrawn
Zanesville, 43701, United States
Withdrawn
San Diego, 92114, United States
Withdrawn
Tomball, 77375, United States
Withdrawn
Annapolis, 21401, United States
Completed
Omaha, 68114, United States
Withdrawn
Tomball, 77375, United States
Completed
Fremont, 94536-3702, United States
Withdrawn
Boston, 02120, United States
Withdrawn
Baltimore, 21237, United States
Completed
Hainesport, 08036, United States
Withdrawn
Houston, 77090, United States
Withdrawn
Chojnice, 89-604, Poland
Completed
Krakow, 31-156, Poland
Withdrawn
Varese, 21100, Italy
Completed
Varese, 21100, Italy
Withdrawn
Varese, 21100, Italy
Withdrawn
Varese, 21100, Italy
Withdrawn
Varese, 21100, Italy
Completed
Varese, 21100, Italy
Withdrawn
Grosseto, 58100, Italy
Completed
Grosseto, 58100, Italy
Withdrawn
Grosseto, 58100, Italy
Completed
Torino, 10023, Italy
Completed
Bergamo, 24128, Italy
Completed
Orocovis, 00720, United States
Completed
San Juan, 00918, United States
Terminated
San Juan, 00918, United States
Withdrawn
Olsztyn, Poland
Completed
Sopot, 81-746, Poland
Completed
Wola, Poland
Withdrawn
Warszawa, 01-961, Poland
Completed
Skierniewice, Poland
Completed
Czechowice-Dziedzice, Poland
Completed
Lublin, 20-044, Poland
Completed
Malaszewicze, Poland
Completed
Bydgoszcz, 85-863, Poland
Completed
Lublin, Poland
Completed
Naklo nad Notecia, 98-100, Poland
Completed
Grodzisk Mazowiecki, 05-825, Poland
Completed
Amandola, 63021, Italy
Completed
Chiavari, 16043, Italy
Completed
Catania, 95124, Italy
Completed
Roma, 00161, Italy
Completed
Roma, 00157, Italy
Completed
Legnano, 20025, Italy
Completed
Chieti, 66100, Italy
Withdrawn
Benevento, 82037, Italy
Withdrawn
Gorizia, 34170, Italy
Completed
Asti, 14100, Italy
Withdrawn
Monza-Brianza, 20052, Italy
Completed
Varese, 21100, Italy
Completed
Krakow, Poland
Completed
Wejherowo, Poland
Completed
Szczyrk, 43-370, Poland
Withdrawn
Tarnow, Poland
Completed
Warszawa, 02-507, Poland
Completed
Bydgoszcz, Poland
Withdrawn
Wejherowo, Poland
Completed
Elblag, 82-300, Poland
Completed
Przeworsk, 37-200, Poland
Withdrawn
Wroclaw, 51-215, Poland
Completed
Kutno, 99-300, Poland
Completed
Ostrow Wielkopolski, 63-400, Poland
Completed
Zabrze, Poland
Completed
Krakow, 31-011, Poland
Completed
Wabrzezno, Poland
Completed
Grosseto, 58100, Italy
Completed
Barcelona, 08023, Spain
Completed
Barcelona, 08023, Spain
Completed
Barcelona, 08025, Spain
Completed
Murcia, 30008, Spain
Completed
Vic (Barcelona), 08500, Spain
Completed
Murcia, 30007, Spain
Completed
Petrer, 03610, Spain
Withdrawn
Orihuela, 03300, Spain
Completed
Oviedo, 33013, Spain
Withdrawn
Gijón, 33212, Spain
Completed
Posada de Llanes, 33594, Spain
Completed
Madrid, 28003, Spain
Completed
León, 24001, Spain
Completed
Zabrze, Poland
Completed
Krakow, 30-424, Poland
Withdrawn
Gniewkowo, 88-140, Poland
Completed
Warszawa, 01-192, Poland
Completed
Gdansk, 80-822, Poland
Completed
Gdansk, 80-461, Poland
Completed
Wroclaw, 50-127, Poland
Completed
Malbork, 82-200, Poland
Completed
Varese, 21100, Italy
Withdrawn
Varese, 21054, Italy
Completed
Varese, 21100, Italy
Completed
Varese, 21100, Italy
Completed
Grosseto, 58100, Italy
Completed
Grosseto, 58100, Italy
Withdrawn
Grosseto, 58100, Italy
Completed
Grosseto, 58100, Italy
Withdrawn
Grosseto, 58100, Italy
Completed
León, 24001, Spain
Withdrawn
León, 24009, Spain
Completed
Oviedo, 33009, Spain
Completed
Lugo, 27770, Spain
Completed
León, Spain
Withdrawn
Alatoz, 02152, Spain
Completed
Viveiro, 27850, Spain
Completed
Madrid, 28032, Spain
Completed
Orense, 32003, Spain
Withdrawn
Alcobendas, 28100, Spain
Completed
Elche, Spain
Completed
Novara, 28100, Italy
Completed
Reggio Emilia, 42019, Italy
Completed
Foggia, 71100, Italy
Withdrawn
Milano, 20122, Italy
Completed
Chieri, 10023, Italy
Completed
Reggio Emilia, 42123, Italy
Withdrawn
Reggio Calabria, 89100, Italy
Completed
Moncalieri, 10024, Italy
Withdrawn
Arezzo, 52100, Italy
Completed
Chieri, 10023, Italy
Completed
Como, 22066, Italy
Completed
Napoli, 80131, Italy
Completed
Badajoz, 06140, Spain
Completed
La Victoria, 38380, Spain
Completed
Gümar, 38591, Spain
Withdrawn
Beniganim, 46830, Spain
Withdrawn
Manises, 46940, Spain
Completed
Benidorm, 03503, Spain
Completed
Enniscorthy, Ireland
Withdrawn
Limerick, Ireland
Withdrawn
Mallow, Ireland
Withdrawn
Cork, Ireland
Withdrawn
Waterford, Ireland
Completed
Cork, Ireland
Completed
Grosseto, 58100, Italy
Withdrawn
Savona, 17100, Italy
Completed
Varese, 21100, Italy
Completed
Alcover, 43460, Spain
Completed
Begonte, 27373, Spain
Completed
Murcia, 300005, Spain
Withdrawn
Murcia, 30003, Spain
Withdrawn
Zarandona, 30007, Spain
Completed
Kilmallock, Ireland
Completed
Tallow, Ireland
Withdrawn
Galway, Ireland
Completed
Dublin, 2, Ireland
Completed
Espinardo, 30100, Spain
Completed
Xixona, 03100, Spain
Withdrawn
Alicante, 03005, Spain
Completed
Alicante, 03007, Spain
Completed
Madrid, 28003, Spain
Completed
Albacete, 2260, Spain
Withdrawn
Valencia, 46006, Spain
Completed
Huelva, 21003, Spain
Completed
Barcelona, 08017, Spain
Withdrawn
Oviedo, 33012, Spain
Withdrawn
León, 24005, Spain
Completed
Salamanca, 27-31, Spain
Withdrawn
Albarán, 30550, Spain
Completed
Sobrado dos Monxes, 15813, Spain
Withdrawn
Chinchilla de Monte Aragón, 02520, Spain
Withdrawn
Badajoz, 06011, Spain
Withdrawn
Albacete, 02005, Spain
Completed
Valladolid, 47007, Spain
Completed
Santander, 39009, Spain
Withdrawn
Salamanca, 37005, Spain
Completed
Madrid, 28030, Spain
Completed
La Roda, 06230, Spain
Completed
Gorey, Ireland
Completed
Bray, Ireland
Completed
Rathkeale, Ireland
Completed
Bishopstown, Ireland
Withdrawn
Rathmines, Ireland
Withdrawn
Tramore, Ireland
Completed
Gorey, Ireland
Withdrawn
Kinvara, Ireland
Completed
Meißen, 01662, Germany

Primary Outcome

  • Time to the first occurrence of the composite outcome of MI (myocardial infarction), stroke, cardiovascular death, UA (unstable angina) or TIA (transient ischemic attack)
    The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
    date_rangeTime Frame:
    Until follow-up (approximate 6 years)

Secondary Outcome

  • Time to the first occurrence of the composite outcome of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown)
    The time to Composite outcome consisting of the first occurrence of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown) was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
    date_rangeTime Frame:
    Until follow-up (approximate 6 years)
  • Time to the first occurrence of the individual components of the primary: non-fatal MI, total MI, non-fatal stroke, total stroke, cardiovascular death, UA and TIA
    The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
    date_rangeTime Frame:
    Until follow-up (approximately 6 years)
  • Time to all-cause mortality, the first occurrence of all cancers excluding non-melanoma skin cancer (NMSC) and the first occurrence of colon cancer
    The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
    date_rangeTime Frame:
    Until follow-up (approximately 6 years)
  • Incidence of all-cause mortality, all cancers excluding non-melanoma skin cancer and colon cancer
    date_rangeTime Frame:
    Until follow-up (approximately 6 years)
  • Incidence of confirmed MI, stroke, cardiovascular death, UA, and TIA separately
    The percentages of subjects with the efficacy endpoints of confirmed MI, stroke, cardiovascular death, UA and TIA are reported separately.
    date_rangeTime Frame:
    Until follow-up (approximately 6 years)

Trial design

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Assess the Efficacy (Reduction of Cardiovascular Disease Events) and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2