Trial Condition(s):
Acute myocardial infarction
Study to gather information about the proper dosing and safety of the oral FXIa inhibitor BAY 2433334 in patients following an acute heart attack (PACIFIC-AMI)
Bayer Identifier:
20603
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of a dual antiplatelet therapy (acetylsalicylic acid +/- clopidogrel) in patients following a recent heart attack (myocardial infarction) that happens when a blood vessel in the heart suddenly becomes blocked. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.
Inclusion Criteria
- Participants must be 45 years of age or older, at the time of signing the informed consent - Acute myocardial infarction (excluding MI associated with PCI or CABG revascularization procedures) with: -- clinical symptoms of acute myocardial infarction AND -- elevated biomarkers of myocardial necrosis (creatine kinase-muscle and brain isoenzyme [CK-MB] or cardiac troponins) AND -- at least one of the following risk factors need to be fulfilled: --- Age ≥ 65 years --- Prior MI (before the index AMI event) --- Prior peripheral arterial disease --- Diabetes Mellitus --- Prior coronary artery bypass grafting (CABG) AND -- initial angiography and revascularization procedures, either PCI or CABG, as treatment for the index event performed before randomization. (Note: a planned, staged PCI procedure can be performed after randomization) - Plan for dual antiplatelet therapy (ASA + P2Y12 inhibitor) after hospital discharge for the index AMI - Randomization during hospitalization for the index AMI event and latest within 5 days of hospital admission - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent has to be signed before any study-specific procedure.
Exclusion Criteria
- Hemodynamically significant ventricular arrhythmias or cardiogenic shock at time of randomization - Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization - Planned use or requirement of full dose and long term anticoagulation therapy during study conduct.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Reid Health Richmond, United States, 47374 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cardiology Associates Research Company Daytona Beach, United States, 32117 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cardiovascular Research of Knoxville Powell, United States, 37849 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PharmaTex Research, LLC Amarillo, United States, 79109 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krankenhaus St. Josef Braunau Braunau, Austria, 5280 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum St. Pölten St. Pölten, Austria, 3100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinik Floridsdorf - Krankenhaus Nord Wien, Austria, 1210 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum Klagenfurt am Wörthersee Klagenfurt, Austria, 9020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinik Ottakring - Wilhelminenspital Wien, Austria, 1160 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Landesklinikum Wiener Neustadt Wiener Neustadt, Austria, 2700 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kepler Universitätsklinikum Campus III Linz, Austria, 4021 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. Milano, Italy, 20089 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Centro Cardiologico Monzino S.p.A Milano, Italy, 20138 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASL TO3 di Collegno e Pinerolo Torino, Italy, 10098 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Ferrara Ferrara, Italy, 44124 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Valle Olona Varese, Italy, 21047 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Ospedale Policlinico San Martino Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASL Caserta Caserta, Italy, 81031 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi" Ancona, Italy, 60126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASL ROMA 2 Roma, Italy, 00157 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ULSS3 Serenissima Venezia, Italy, 30035 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. San Pio Benevento, Italy, 82100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. S.Croce e Carle Cuneo, Italy, 12100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Sassari Sassari, Italy | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL Toscana Sud-Est Grosseto, Italy, 58100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southern Clinical Research, LLC Zachary, United States, 70791 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cardiovascular Associates Research, LLC Covington, United States, 70433 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Mary's/Duluth Clinic Health System Duluth, United States, 55805 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Columbus Regional Research Institute Columbus, United States, 31904 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Midwest Heart & Vascular Specialists Overland Park, United States, 66211 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations North Texas Research Associates McKinney, United States, 75071 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Methodist Physicians Clinic Omaha, United States, 68114 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Trinity Medical WNY Cheektowaga, United States, 14227 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Valley Clinical Trials, Inc. - Covina Covina, United States, 91723 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cardiology Partners Clinical Research Institute Palm Beach Gardens, United States, 33410 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jefferson Heart Institute Philadelphia, United States, 19107 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Logan Health Research Kalispell, United States, 59901 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne, Switzerland, 1011 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Cantonal Universitaire de Genève Genève, Switzerland, 1205 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale regionale di Lugano Lugano, Switzerland, 6900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Luzerner Kantonsspital Luzern, Switzerland, 6000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kantonsspital Aarau Aarau, Switzerland, 5001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kantonsspital Baselland - Standort Liestal Liestal, Switzerland, 4410 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kantonsspital Baden Baden, Switzerland, 5404 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Maryland Cardiovascular Specialists Baltimore, United States, 21229 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Valley Hospital, Inc. Ridgewood, United States, 07450 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szpital Grochowski im. dr.med. Rafala Masztaka Warszawa, Poland, 04-073 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szpital sw. Wincentego a Paulo Gdynia, Poland, 81-348 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniwersytecki Szpital Kliniczny UM we Wroclawiu Wroclaw, Poland, 50-556 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniwersyteckie Centrum Kliniczne Warszawskiego UM Warszawa, Poland, 02-097 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniwersytecki Szpital Kliniczny w Opolu Opole, Poland, 45-401 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, Poland, 15-276 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samodzielny Publiczny Specjalistyczny Szpital Zachodni Grodzisk Mazowiecki, Poland, 05-825 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ziekenhuis Oost-Limburg GENK, Belgium, 3600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Sint-Jan Brugge-Oostende | Sint-Jan - Cardiology BRUGGE, Belgium, 8000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations OL Vrouwziekenhuis - Campus Aalst AALST, Belgium, 9300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sahlgrenska Universitetssjukhuset Göteborg, Sweden, 413 45 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Danderyds sjukhus Stockholm, Sweden, 182 88 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Länssjukhuset Ryhov Jönköping, Sweden, 551 85 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Skånes Universitetssjukhus Lund, Sweden, 222 42 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Falu Lasarett Falun, Sweden, 791 82 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Akademiska sjukhuset Hjärtforskningsmottagningen Uppsala, Sweden, 751 85 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Länssjukhuset Sundsvall-Härnösand Sundsvall, Sweden, 851 86 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Västmanlands Sjukhus Västerås Västerås, Sweden, 721 89 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitetssjukhuset Örebro Örebro, Sweden, 701 85 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Imeldaziekenhuis - St-Elisabethkliniek Bonheiden, Belgium, 2820 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jessa Ziekenhuis HASSELT, Belgium, 3500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHR de la Citadelle - Cardiology LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Petz Aladar Megyei Oktato Korhaz Gyor, Hungary, 9023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Allami Szivkorhaz Balatonfured, Hungary, 8230 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pandy Kalman Korhaz Gyula, Hungary, 5700 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eszak-Pesti Centrumkorhaz-Honvedkorhaz Budapest, Hungary | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Josa Andras Hospital Nyiregyhaza, Hungary, H-4400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zala Megyei Szent Rafael Korhaz Zalaegerszeg, Hungary, 8900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Semmelweis/ Semmelweis Egyetem Budapest, Hungary, 1122 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Budai Irgalmasrendi Korhaz Budapest, Hungary, 1023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvar, Hungary, 7400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Slany Slany, Czech Republic, 274 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice u sv. Anny Brno, Czech Republic, 656 91 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Klinicke a Experimentalni Mediciny Praha 4, Czech Republic, 140 21 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Plzen - Lochotin Plzen, Czech Republic, 304 60 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vseobecna fakultni nemocnice v Praze Praha 2, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice v Motole Praha 5, Czech Republic, 150 06 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Ceske Budejovice, a.s. Department of kardiologie Ceske Budejovice, Czech Republic, 370 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni Nemocnice Hradec Kralove Hradec Kralove, Czech Republic, 500 05 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ustredni vojenska nemocnice Praha Praha 6, Czech Republic, 169 02 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Brno Brno, Czech Republic, 625 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 10034 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saitama Sekishinkai Hospital Sayama, Japan, 350-1305 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ogaki Municipal Hospital Ogaki, Japan, 503-8502 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shin-Kuki General Hospital Kuki, Japan, 346-8530 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chiba-Nishi General Hospital Matsudo, Japan, 270-2251 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tsukuba Medical Center Hospital Tsukuba, Japan, 305-8558 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kishiwada Tokushukai Hospital Kishiwada, Japan, 596-0042 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kokura Memorial Hospital Kitakyushu, Japan, 802-8555 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hyogo Prefectural Harima-Himeji General Medical Center Himeji, Japan, 670-8560 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saiseikai Kumamoto Hospital Kumamoto, Japan, 861-4193 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oita Prefectural Hospital Oita, Japan, 870-8511 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hokkaido Cardiovascular Hospital Sapporo, Japan, 064-8622 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Daido Hospital, Social Medical Corporation Kojunkai Nagoya, Japan, 457-8511 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Fukuoka Hospital Fukuoka, Japan, 815-8555 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukui Prefectural Hospital Fukui, Japan, 910-8526 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokyo Medical and Dental University Hospital Bunkyo-ku, Japan, 113-8519 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bravis Ziekenhuis ROOSENDAAL, Netherlands, 4708 AE | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gelre Ziekenhuizen Zutphen ZUTPHEN, Netherlands, 7207 AE | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ikazia Ziekenhuis Rotterdam, Netherlands, 3083 AN | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitair Medisch Centrum St. Radboud NIJMEGEN, Netherlands, 6500 HB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Albert Schweitzer Ziekenhuis, Dordwijk DORDRECHT, Netherlands, 3318 AT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Elkerliek Ziekenhuis, Lokatie Helmond HELMOND, Netherlands, 5707 HA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Reinier de Graaf Gasthuis DELFT, Netherlands, 2625 AD | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jeroen Bosch Ziekenhuis DEN BOSCH, Netherlands, 5223 GZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Canisius Wilhelmina Ziekenhuis NIJMEGEN, Netherlands, 6532 SZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zuyderland Medisch Centrum HEERLEN, Netherlands, 6419 PC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Isala Zwolle, Netherlands, 8025 AZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Noord West Ziekenhuisgroep-Medisch Centrum Alkmaar ALKMAAR, Netherlands, 1815 JD | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Leids Universitair Medisch Centrum LEIDEN, Netherlands, 2333 ZA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations VieCuri - Medisch Centrum voor Noord-Limburg locatie Venlo VENLO, Netherlands, 5912 BL | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsmedizin der Johannes Gutenberg Universität Mainz Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsherzzentrum Freiburg - Bad Krozingen Bad Krozingen, Germany, 79189 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kliniken Maria Hilf GmbH Mönchengladbach, Germany, 41063 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Essen Essen, Germany, 45147 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Hamburg Eppendorf (UKE) Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Vinzenz-Hospital Köln, Germany, 50733 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Forschungszentrum Ruhr - KliFoCenter GmbH Witten, Germany, 58455 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69120 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krankenhaus Dresden-Friedrichstadt Dresden, Germany, 01067 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kanagawa Cardiovascular and Respiratory Center Yokohama, Japan, 236-0051 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nishinomiya Watanabe Cardiovascular Center Nishinomiya, Japan, 662-0911 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukuoka Tokushukai Hospital Kasuga, Japan, 816-0864 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Takahashi Hospital Kobe, Japan, 654-0026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de la Santa Creu i de Sant Pau | Cardiología Barcelona, Spain, 08041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clinico Universitario Virgen de la Arrixaca | Neurology Department - Stroke Murcia, Spain, 30120 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de las Nieves|Cardiologia Granada, Spain, 18014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Gral. Univ. de Valencia | Cardiologia Valencia, Spain, 46014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de la Macarena Sevilla, Spain, 41071 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clinico Universitario San Carlos | Cardiologia Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inst Investigacio Sanitaria Pere Virgili | Hosp Univ Joan XXIII de Tarragona - Neurology - Stroke, No-Cardioembolic-Tia Tarragona, Spain, 43005 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention Barcelona, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Ramon y Cajal | Cardiologia Madrid, Spain, 28034 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari i Politècnic La Fe | Cardiología Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz Szolnok, Hungary, 5000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osaka General Medical Center Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej Rzeszow, Poland, 35-301 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sana-Klinikum Remscheid GmbH Remscheid, Germany, 42859 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations White Oak Medical Center Silver Spring, United States, 20904 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clearwater Cardiovascular Associates | Clearwater, FL Clearwater, United States, 33756 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Premier Cardiology Boyton Beach, United States, 33437 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wythenshawe Hospital Manchester, United Kingdom, M23 9LT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Worcestershire Acute Hospital Trust Worcester, United Kingdom, WR5 1DD | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lister Hospital Stevenage, United Kingdom, SG1 4AB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Freeman Hospital Newcastle Upon Tyne, United Kingdom, NE7 7DN | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Imperial College London London, United Kingdom, W12 0HS | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southwest Florida Research Naples, United States, 34102 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Multicenter, randomized, placebo controlled, double-blind, parallel group, dose-finding Phase 2 study to evaluate the efficacy and safety of BAY 2433334 in patients following an acute myocardial infarction
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Efficacy - Number of participants with composite of CV death, MI, stroke and stent thrombosis (ST)CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included. Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. Stroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction. ST was defined incorporating diagnostic certainty as well as timing: “Definite” ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. “Probable” ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious causeTimeframe: From baseline up to 52 weeks
- Safety - Number of participants with BARC bleeding definition type 2, 3 and 5Type 2: any overt, actionable sign of hemorrhage that doesn’t fit the criteria for type 3 or 5 but meets at least one of the following criteria: 1) requires nonsurgical, med intervention by a HCP, 2) leads to hospital or rise in level of care, or 3) prompt eval. Type 3a: 1) overt bleed + Hg drop of 3 to <5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn’t include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation.Timeframe: From baseline up to 52 weeks
Secondary Outcome
- Efficacy - Number of participants with CV deathCV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included.Timeframe: From baseline up to 52 weeks
- Efficacy - Number of participants with MIAcute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. According to MI Universal Definition from 2018 the diagnosis of MI requires combination of: 1. Presence of acute myocardial injury. 2. Evidence of acute myocardial ischemia derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging, or in case of post-mortem pathological findings irrespective of biomarker values.Timeframe: From baseline up to 52 weeks
- Efficacy - Number of participants with strokeStroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction.Timeframe: From baseline up to 52 weeks
- Efficacy - Number of participants with stent thrombosisST was defined incorporating diagnostic certainty as well as timing: “Definite” ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. “Probable” ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious causeTimeframe: From baseline up to 52 weeks
- Efficacy - Number of participants with all cause mortalityTimeframe: From baseline up to 52 weeks
- Safety - Number of participants with all bleedingAll bleeding events occurred from first intake of study intervention until 2 days after the last intake of study interventionTimeframe: From baseline up to 52 weeks
- Safety - Number of participants with BARC bleeding definition type 3, 5BARC bleeding Type 3,5 definition, please refer to primary endpoint "Number of participants with BARC bleeding definition type 2, 3 and 5".Timeframe: From baseline up to 52 weeks
- Safety - Number of participants with BARC bleeding definition type 1,2,3,5Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consulting a healthcare professional. BARC bleeding Type 2,3,5 definition, please refer to primary endpoint "Number of participants with BARC bleeding definition type 2, 3 and 5".Timeframe: From baseline up to 52 weeks
Additional Information
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