check_circleStudy Completed
Acute myocardial infarction
Bayer Identifier:
20603
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study to gather information about the proper dosing and safety of the oral FXIa inhibitor BAY 2433334 in patients following an acute heart attack
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.
Key Participants Requirements
Sex
AllAge
45 - N/ATrial summary
Enrollment Goal
1601Trial Dates
June 2020 - February 2022Phase
Phase 2Could I Receive a placebo
NoProducts
Asundexian (BAY2433334)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Reid Health | Richmond, 47374, United States |
Completed | Cardiology Associates Research Company | Daytona Beach, 32117, United States |
Withdrawn | AdventHealth Tampa | Tampa, 33613, United States |
Completed | Cardiovascular Research of Knoxville | Powell, 37849, United States |
Completed | PharmaTex Research, LLC | Amarillo, 79109, United States |
Completed | Krankenhaus St. Josef Braunau | Braunau, 5280, Austria |
Completed | Universitätsklinikum St. Pölten | St. Pölten, 3100, Austria |
Completed | Klinik Floridsdorf - Krankenhaus Nord | Wien, 1210, Austria |
Completed | Klinikum Klagenfurt am Wörthersee | Klagenfurt, 9020, Austria |
Completed | Klinik Ottakring - Wilhelminenspital | Wien, 1160, Austria |
Completed | Medizinische Universität Graz | Graz, 8036, Austria |
Completed | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Withdrawn | Ordensklinikum Linz GmbH Elisabethinen | Linz, 4020, Austria |
Completed | Landesklinikum Wiener Neustadt | Wiener Neustadt, 2700, Austria |
Completed | Kepler Universitätsklinikum Campus III | Linz, 4021, Austria |
Completed | Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. | Milano, 20089, Italy |
Completed | IRCCS Centro Cardiologico Monzino S.p.A | Milano, 20138, Italy |
Completed | ASL TO3 di Collegno e Pinerolo | Torino, 10098, Italy |
Completed | A.O.U. di Ferrara | Ferrara, 44124, Italy |
Completed | ASST Valle Olona | Varese, 21047, Italy |
Completed | IRCCS Ospedale Policlinico San Martino | Genova, 16132, Italy |
Completed | ASL Caserta | Caserta, 81031, Italy |
Completed | A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi" | Ancona, 60126, Italy |
Withdrawn | Eurosanità SpA | Roma, 00169, Italy |
Completed | ASL ROMA 2 | Roma, 00157, Italy |
Completed | ULSS3 Serenissima | Venezia, 30035, Italy |
Completed | A.O. San Pio | Benevento, 82100, Italy |
Completed | A.O. S.Croce e Carle | Cuneo, 12100, Italy |
Completed | A.O.U. di Sassari | Sassari, Italy |
Completed | AUSL Toscana Sud-Est | Grosseto, 58100, Italy |
Completed | Southern Clinical Research, LLC | Zachary, 70791, United States |
Completed | Cardiovascular Associates Research, LLC | Covington, 70433, United States |
Completed | St. Mary's/Duluth Clinic Health System | Duluth, 55805, United States |
Completed | Columbus Regional Research Institute | Columbus, 31904, United States |
Withdrawn | Monument Health Clinical Research | Rapid City, 57701, United States |
Completed | Midwest Heart & Vascular Specialists | Overland Park, 66211, United States |
Withdrawn | Valley Clinical Trials, Inc. - Northridge | Northridge, 91325, United States |
Withdrawn | Wichita Falls Heart Clinic | Wichita Falls, 76301, United States |
Completed | North Texas Research Associates | McKinney, 75071, United States |
Completed | Methodist Physicians Clinic | Omaha, 68114, United States |
Withdrawn | Universitätsspital Basel | Basel, 4056, Switzerland |
Completed | Trinity Medical WNY | Cheektowaga, 14227, United States |
Completed | Valley Clinical Trials, Inc. - Covina | Covina, 91723, United States |
Completed | Cardiology Partners Clinical Research Institute | Palm Beach Gardens, 33410, United States |
Completed | Jefferson Heart Institute | Philadelphia, 19107, United States |
Completed | Logan Health Research | Kalispell, 59901, United States |
Completed | Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne, 1011, Switzerland |
Completed | Hôpital Cantonal Universitaire de Genève | Genève, 1205, Switzerland |
Completed | Ospedale regionale di Lugano | Lugano, 6900, Switzerland |
Completed | Luzerner Kantonsspital | Luzern, 6000, Switzerland |
Completed | Kantonsspital Aarau | Aarau, 5001, Switzerland |
Completed | Kantonsspital Baselland - Standort Liestal | Liestal, 4410, Switzerland |
Completed | Kantonsspital Baden | Baden, 5404, Switzerland |
Completed | Maryland Cardiovascular Specialists | Baltimore, 21229, United States |
Completed | The Valley Hospital, Inc. | Ridgewood, 07450, United States |
Completed | Szpital Grochowski im. dr.med. Rafala Masztaka | Warszawa, 04-073, Poland |
Completed | Szpital sw. Wincentego a Paulo | Gdynia, 81-348, Poland |
Completed | Uniwersytecki Szpital Kliniczny UM we Wroclawiu | Wroclaw, 50-556, Poland |
Completed | Uniwersyteckie Centrum Kliniczne Warszawskiego UM | Warszawa, 02-097, Poland |
Withdrawn | Slaskie Centrum Chorob Serca | Zabrze, 41-800, Poland |
Completed | Uniwersytecki Szpital Kliniczny w Opolu | Opole, 45-401, Poland |
Completed | Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok, 15-276, Poland |
Completed | Samodzielny Publiczny Specjalistyczny Szpital Zachodni | Grodzisk Mazowiecki, 05-825, Poland |
Completed | Ziekenhuis Oost-Limburg | GENK, 3600, Belgium |
Completed | AZ Sint-Jan Brugge-Oostende | Sint-Jan - Cardiology | BRUGGE, 8000, Belgium |
Completed | OL Vrouwziekenhuis - Campus Aalst | AALST, 9300, Belgium |
Completed | CU Saint-Luc/UZ St-Luc | BRUXELLES - BRUSSEL, 1200, Belgium |
Completed | Sahlgrenska Universitetssjukhuset | Göteborg, 413 45, Sweden |
Completed | Danderyds sjukhus | Stockholm, 182 88, Sweden |
Completed | Länssjukhuset Ryhov | Jönköping, 551 85, Sweden |
Completed | Skånes Universitetssjukhus | Lund, 222 42, Sweden |
Completed | Falu Lasarett | Falun, 791 82, Sweden |
Completed | Akademiska sjukhuset Hjärtforskningsmottagningen | Uppsala, 751 85, Sweden |
Completed | Länssjukhuset Sundsvall-Härnösand | Sundsvall, 851 86, Sweden |
Completed | Västmanlands Sjukhus Västerås | Västerås, 721 89, Sweden |
Completed | Universitetssjukhuset Örebro | Örebro, 701 85, Sweden |
Withdrawn | Östersunds Sjukhus | Östersund, 831 83, Sweden |
Completed | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Completed | Imeldaziekenhuis - St-Elisabethkliniek | Bonheiden, 2820, Belgium |
Completed | Jessa Ziekenhuis | HASSELT, 3500, Belgium |
Completed | CHR de la Citadelle - Cardiology | LIEGE, 4000, Belgium |
Completed | Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary |
Completed | Petz Aladar Megyei Oktato Korhaz | Gyor, 9023, Hungary |
Completed | Allami Szivkorhaz | Balatonfured, 8230, Hungary |
Completed | Pandy Kalman Korhaz | Gyula, 5700, Hungary |
Completed | Eszak-Pesti Centrumkorhaz-Honvedkorhaz | Budapest, Hungary |
Completed | Josa Andras Hospital | Nyiregyhaza, H-4400, Hungary |
Completed | Zala Megyei Szent Rafael Korhaz | Zalaegerszeg, 8900, Hungary |
Completed | University of Semmelweis/ Semmelweis Egyetem | Budapest, 1122, Hungary |
Completed | Budai Irgalmasrendi Korhaz | Budapest, 1023, Hungary |
Completed | Somogy Megyei Kaposi Mor Oktato Korhaz | Kaposvar, 7400, Hungary |
Withdrawn | Bacs-Kiskun Megyei Korhaz | Kecskemét, 6000, Hungary |
Completed | Nemocnice Slany | Slany, 274 01, Czechia |
Completed | Fakultni nemocnice u sv. Anny | Brno, 656 91, Czechia |
Completed | Institut Klinicke a Experimentalni Mediciny | Praha 4, 140 21, Czechia |
Completed | Fakultni nemocnice Plzen - Lochotin | Plzen, 304 60, Czechia |
Completed | Vseobecna fakultni nemocnice v Praze | Praha 2, 12808, Czechia |
Completed | Fakultni nemocnice v Motole | Praha 5, 150 06, Czechia |
Completed | Nemocnice Ceske Budejovice, a.s. Department of kardiologie | Ceske Budejovice, 370 01, Czechia |
Completed | Fakultni Nemocnice Hradec Kralove | Hradec Kralove, 500 05, Czechia |
Completed | Ustredni vojenska nemocnice Praha | Praha 6, 169 02, Czechia |
Completed | Fakultni nemocnice Brno | Brno, 625 00, Czechia |
Completed | Fakultni nemocnice Kralovske Vinohrady | Praha 10, 10034, Czechia |
Withdrawn | Krajska Nemocnice Liberec | Liberec, 460 63, Czechia |
Completed | Saitama Sekishinkai Hospital | Sayama, 350-1305, Japan |
Completed | Ogaki Municipal Hospital | Ogaki, 503-8502, Japan |
Completed | Shin-Kuki General Hospital | Kuki, 346-8530, Japan |
Completed | Chiba-Nishi General Hospital | Matsudo, 270-2251, Japan |
Completed | Tsukuba Medical Center Hospital | Tsukuba, 305-8558, Japan |
Completed | Kishiwada Tokushukai Hospital | Kishiwada, 596-0042, Japan |
Completed | Kokura Memorial Hospital | Kitakyushu, 802-8555, Japan |
Completed | Hyogo Prefectural Harima-Himeji General Medical Center | Himeji, 670-8560, Japan |
Completed | Saiseikai Kumamoto Hospital | Kumamoto, 861-4193, Japan |
Completed | Oita Prefectural Hospital | Oita, 870-8511, Japan |
Completed | Hokkaido Cardiovascular Hospital | Sapporo, 064-8622, Japan |
Completed | Daido Hospital, Social Medical Corporation Kojunkai | Nagoya, 457-8511, Japan |
Completed | Japanese Red Cross Fukuoka Hospital | Fukuoka, 815-8555, Japan |
Withdrawn | Tsuchiura Kyodo General Hospital | Tsuchiura, 300-0028, Japan |
Completed | Fukui Prefectural Hospital | Fukui, 910-8526, Japan |
Completed | Tokyo Medical and Dental University Hospital | Bunkyo-ku, 113-8519, Japan |
Completed | Bravis Ziekenhuis | ROOSENDAAL, 4708 AE, Netherlands |
Completed | Gelre Ziekenhuizen Zutphen | ZUTPHEN, 7207 AE, Netherlands |
Completed | Ikazia Ziekenhuis | Rotterdam, 3083 AN, Netherlands |
Completed | Universitair Medisch Centrum St. Radboud | NIJMEGEN, 6500 HB, Netherlands |
Completed | Albert Schweitzer Ziekenhuis, Dordwijk | DORDRECHT, 3318 AT, Netherlands |
Completed | Elkerliek Ziekenhuis, Lokatie Helmond | HELMOND, 5707 HA, Netherlands |
Completed | Reinier de Graaf Gasthuis | DELFT, 2625 AD, Netherlands |
Completed | Jeroen Bosch Ziekenhuis | DEN BOSCH, 5223 GZ, Netherlands |
Completed | Canisius Wilhelmina Ziekenhuis | NIJMEGEN, 6532 SZ, Netherlands |
Completed | Zuyderland Medisch Centrum | HEERLEN, 6419 PC, Netherlands |
Completed | Isala | Zwolle, 8025 AZ, Netherlands |
Completed | Noord West Ziekenhuisgroep-Medisch Centrum Alkmaar | ALKMAAR, 1815 JD, Netherlands |
Completed | Leids Universitair Medisch Centrum | LEIDEN, 2333 ZA, Netherlands |
Completed | VieCuri - Medisch Centrum voor Noord-Limburg locatie Venlo | VENLO, 5912 BL, Netherlands |
Completed | Universitätsmedizin der Johannes Gutenberg Universität Mainz | Mainz, 55131, Germany |
Completed | Universitätsherzzentrum Freiburg - Bad Krozingen | Bad Krozingen, 79189, Germany |
Completed | Kliniken Maria Hilf GmbH | Mönchengladbach, 41063, Germany |
Completed | Universitätsklinikum Essen | Essen, 45147, Germany |
Completed | Universitätsklinikum Hamburg Eppendorf (UKE) | Hamburg, 20246, Germany |
Completed | St. Vinzenz-Hospital | Köln, 50733, Germany |
Completed | Forschungszentrum Ruhr - KliFoCenter GmbH | Witten, 58455, Germany |
Completed | Universitätsklinikum Heidelberg | Heidelberg, 69120, Germany |
Completed | Krankenhaus Dresden-Friedrichstadt | Dresden, 01067, Germany |
Completed | Kanagawa Cardiovascular and Respiratory Center | Yokohama, 236-0051, Japan |
Completed | Nishinomiya Watanabe Cardiovascular Center | Nishinomiya, 662-0911, Japan |
Completed | Fukuoka Tokushukai Hospital | Kasuga, 816-0864, Japan |
Completed | Takahashi Hospital | Kobe, 654-0026, Japan |
Completed | Hospital de la Santa Creu i de Sant Pau | Cardiología | Barcelona, 08041, Spain |
Completed | Hospital Clinico Universitario Virgen de la Arrixaca | Neurology Department - Stroke | Murcia, 30120, Spain |
Completed | Hospital Universitario Virgen de las Nieves|Cardiologia | Granada, 18014, Spain |
Completed | Hospital Gral. Univ. de Valencia | Cardiologia | Valencia, 46014, Spain |
Completed | Hospital Universitario Virgen de la Macarena | Sevilla, 41071, Spain |
Completed | Hospital Clinico Universitario San Carlos | Cardiologia | Madrid, 28040, Spain |
Completed | Hospital Universitario 12 de Octubre | Madrid, 28041, Spain |
Completed | Inst Investigacio Sanitaria Pere Virgili | Hosp Univ Joan XXIII de Tarragona - Neurology - Stroke, No-Cardioembolic-Tia | Tarragona, 43005, Spain |
Completed | Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention | Barcelona, 08907, Spain |
Completed | Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Completed | Hospital Ramon y Cajal | Cardiologia | Madrid, 28034, Spain |
Completed | Hospital Universitari i Politècnic La Fe | Cardiología | Valencia, 46026, Spain |
Withdrawn | Victoria Heart Institute Foundation | Victoria, V8R 1B2, Canada |
Withdrawn | Surrey Memorial Hospital | Surrey, V3V 1Z2, Canada |
Withdrawn | Edmonton Cardiology Consultant | Edmonton, T5H 3V9, Canada |
Withdrawn | Hamilton General Hospital | Hamilton, L8L 2X2, Canada |
Withdrawn | St. Michael's Hospital Health Centre | Toronto, M5B 1W8, Canada |
Withdrawn | London Health Sciences Centre | London, N6A 5A5, Canada |
Withdrawn | University of Ottawa Heart Institute | Ottawa, K1Y 4W7, Canada |
Withdrawn | CHUM - Centre hospitalier de l'Université de Montréal | Montreal, H2X 3H8, Canada |
Withdrawn | Institute de Cardiologie de Montreal | Montreal, H1T 1C8, Canada |
Withdrawn | Hopital Laval | Quebec, G6X 2H5, Canada |
Withdrawn | York PCI Group Inc. | Newmarket, L3Y 2P7, Canada |
Completed | Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz | Szolnok, 5000, Hungary |
Completed | Osaka General Medical Center | Osaka, 558-8558, Japan |
Completed | Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej | Rzeszow, 35-301, Poland |
Withdrawn | 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ | Bydgoszcz, 85-681, Poland |
Completed | Sana-Klinikum Remscheid GmbH | Remscheid, 42859, Germany |
Completed | White Oak Medical Center | Silver Spring, 20904, United States |
Completed | Clearwater Cardiovascular Associates | Clearwater, FL | Clearwater, 33756, United States |
Completed | Florida Premier Cardiology | Boyton Beach, 33437, United States |
Withdrawn | Queen Elizabeth Hospital | Birmingham, B15 2TH, United Kingdom |
Completed | Wythenshawe Hospital | Manchester, M23 9LT, United Kingdom |
Completed | Worcestershire Acute Hospital Trust | Worcester, WR5 1DD, United Kingdom |
Completed | Lister Hospital | Stevenage, SG1 4AB, United Kingdom |
Completed | Freeman Hospital | Newcastle Upon Tyne, NE7 7DN, United Kingdom |
Completed | Imperial College London | London, W12 0HS, United Kingdom |
Completed | Southwest Florida Research | Naples, 34102, United States |
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 causedate_rangeTime Frame: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.date_rangeTime Frame: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.date_rangeTime Frame: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.date_rangeTime Frame: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.date_rangeTime Frame: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 causedate_rangeTime Frame:From baseline up to 52 weeks
- Efficacy - Number of participants with all cause mortalitydate_rangeTime Frame: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 interventiondate_rangeTime Frame: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".date_rangeTime Frame: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".date_rangeTime Frame:From baseline up to 52 weeks
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
4