check_circleStudy Completed

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

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

All

Age

45 - N/A
  • - 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.
  • - 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
1601
Trial Dates
June 2020 - February 2022
Phase
Phase 2
Could I Receive a placebo
No
Products
Asundexian (BAY2433334)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Reid HealthRichmond, 47374, United States
Completed
Cardiology Associates Research CompanyDaytona Beach, 32117, United States
Withdrawn
AdventHealth TampaTampa, 33613, United States
Completed
Cardiovascular Research of KnoxvillePowell, 37849, United States
Completed
PharmaTex Research, LLCAmarillo, 79109, United States
Completed
Krankenhaus St. Josef BraunauBraunau, 5280, Austria
Completed
Universitätsklinikum St. PöltenSt. Pölten, 3100, Austria
Completed
Klinik Floridsdorf - Krankenhaus NordWien, 1210, Austria
Completed
Klinikum Klagenfurt am WörtherseeKlagenfurt, 9020, Austria
Completed
Klinik Ottakring - WilhelminenspitalWien, 1160, Austria
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Withdrawn
Ordensklinikum Linz GmbH ElisabethinenLinz, 4020, Austria
Completed
Landesklinikum Wiener NeustadtWiener Neustadt, 2700, Austria
Completed
Kepler Universitätsklinikum Campus IIILinz, 4021, Austria
Completed
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.Milano, 20089, Italy
Completed
IRCCS Centro Cardiologico Monzino S.p.AMilano, 20138, Italy
Completed
ASL TO3 di Collegno e PineroloTorino, 10098, Italy
Completed
A.O.U. di FerraraFerrara, 44124, Italy
Completed
ASST Valle OlonaVarese, 21047, Italy
Completed
IRCCS Ospedale Policlinico San MartinoGenova, 16132, Italy
Completed
ASL CasertaCaserta, 81031, Italy
Completed
A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"Ancona, 60126, Italy
Withdrawn
Eurosanità SpARoma, 00169, Italy
Completed
ASL ROMA 2Roma, 00157, Italy
Completed
ULSS3 SerenissimaVenezia, 30035, Italy
Completed
A.O. San PioBenevento, 82100, Italy
Completed
A.O. S.Croce e CarleCuneo, 12100, Italy
Completed
A.O.U. di SassariSassari, Italy
Completed
AUSL Toscana Sud-EstGrosseto, 58100, Italy
Completed
Southern Clinical Research, LLCZachary, 70791, United States
Completed
Cardiovascular Associates Research, LLCCovington, 70433, United States
Completed
St. Mary's/Duluth Clinic Health SystemDuluth, 55805, United States
Completed
Columbus Regional Research InstituteColumbus, 31904, United States
Withdrawn
Monument Health Clinical ResearchRapid City, 57701, United States
Completed
Midwest Heart & Vascular SpecialistsOverland Park, 66211, United States
Withdrawn
Valley Clinical Trials, Inc. - NorthridgeNorthridge, 91325, United States
Withdrawn
Wichita Falls Heart ClinicWichita Falls, 76301, United States
Completed
North Texas Research AssociatesMcKinney, 75071, United States
Completed
Methodist Physicians ClinicOmaha, 68114, United States
Withdrawn
Universitätsspital BaselBasel, 4056, Switzerland
Completed
Trinity Medical WNYCheektowaga, 14227, United States
Completed
Valley Clinical Trials, Inc. - CovinaCovina, 91723, United States
Completed
Cardiology Partners Clinical Research InstitutePalm Beach Gardens, 33410, United States
Completed
Jefferson Heart InstitutePhiladelphia, 19107, United States
Completed
Logan Health ResearchKalispell, 59901, United States
Completed
Centre Hospitalier Universitaire Vaudois (CHUV)Lausanne, 1011, Switzerland
Completed
Hôpital Cantonal Universitaire de GenèveGenève, 1205, Switzerland
Completed
Ospedale regionale di LuganoLugano, 6900, Switzerland
Completed
Luzerner KantonsspitalLuzern, 6000, Switzerland
Completed
Kantonsspital AarauAarau, 5001, Switzerland
Completed
Kantonsspital Baselland - Standort LiestalLiestal, 4410, Switzerland
Completed
Kantonsspital BadenBaden, 5404, Switzerland
Completed
Maryland Cardiovascular SpecialistsBaltimore, 21229, United States
Completed
The Valley Hospital, Inc.Ridgewood, 07450, United States
Completed
Szpital Grochowski im. dr.med. Rafala MasztakaWarszawa, 04-073, Poland
Completed
Szpital sw. Wincentego a PauloGdynia, 81-348, Poland
Completed
Uniwersytecki Szpital Kliniczny UM we WroclawiuWroclaw, 50-556, Poland
Completed
Uniwersyteckie Centrum Kliniczne Warszawskiego UMWarszawa, 02-097, Poland
Withdrawn
Slaskie Centrum Chorob SercaZabrze, 41-800, Poland
Completed
Uniwersytecki Szpital Kliniczny w OpoluOpole, 45-401, Poland
Completed
Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, 15-276, Poland
Completed
Samodzielny Publiczny Specjalistyczny Szpital ZachodniGrodzisk Mazowiecki, 05-825, Poland
Completed
Ziekenhuis Oost-LimburgGENK, 3600, Belgium
Completed
AZ Sint-Jan Brugge-Oostende | Sint-Jan - CardiologyBRUGGE, 8000, Belgium
Completed
OL Vrouwziekenhuis - Campus AalstAALST, 9300, Belgium
Completed
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
Sahlgrenska UniversitetssjukhusetGöteborg, 413 45, Sweden
Completed
Danderyds sjukhusStockholm, 182 88, Sweden
Completed
Länssjukhuset RyhovJönköping, 551 85, Sweden
Completed
Skånes UniversitetssjukhusLund, 222 42, Sweden
Completed
Falu LasarettFalun, 791 82, Sweden
Completed
Akademiska sjukhuset HjärtforskningsmottagningenUppsala, 751 85, Sweden
Completed
Länssjukhuset Sundsvall-HärnösandSundsvall, 851 86, Sweden
Completed
Västmanlands Sjukhus VästeråsVästerås, 721 89, Sweden
Completed
Universitetssjukhuset ÖrebroÖrebro, 701 85, Sweden
Withdrawn
Östersunds SjukhusÖstersund, 831 83, Sweden
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
Imeldaziekenhuis - St-ElisabethkliniekBonheiden, 2820, Belgium
Completed
Jessa ZiekenhuisHASSELT, 3500, Belgium
Completed
CHR de la Citadelle - CardiologyLIEGE, 4000, Belgium
Completed
Debreceni Egyetem Klinikai KozpontDebrecen, 4032, Hungary
Completed
Petz Aladar Megyei Oktato KorhazGyor, 9023, Hungary
Completed
Allami SzivkorhazBalatonfured, 8230, Hungary
Completed
Pandy Kalman KorhazGyula, 5700, Hungary
Completed
Eszak-Pesti Centrumkorhaz-HonvedkorhazBudapest, Hungary
Completed
Josa Andras HospitalNyiregyhaza, H-4400, Hungary
Completed
Zala Megyei Szent Rafael KorhazZalaegerszeg, 8900, Hungary
Completed
University of Semmelweis/ Semmelweis EgyetemBudapest, 1122, Hungary
Completed
Budai Irgalmasrendi KorhazBudapest, 1023, Hungary
Completed
Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, 7400, Hungary
Withdrawn
Bacs-Kiskun Megyei KorhazKecskemét, 6000, Hungary
Completed
Nemocnice SlanySlany, 274 01, Czechia
Completed
Fakultni nemocnice u sv. AnnyBrno, 656 91, Czechia
Completed
Institut Klinicke a Experimentalni MedicinyPraha 4, 140 21, Czechia
Completed
Fakultni nemocnice Plzen - LochotinPlzen, 304 60, Czechia
Completed
Vseobecna fakultni nemocnice v PrazePraha 2, 12808, Czechia
Completed
Fakultni nemocnice v MotolePraha 5, 150 06, Czechia
Completed
Nemocnice Ceske Budejovice, a.s. Department of kardiologieCeske Budejovice, 370 01, Czechia
Completed
Fakultni Nemocnice Hradec KraloveHradec Kralove, 500 05, Czechia
Completed
Ustredni vojenska nemocnice PrahaPraha 6, 169 02, Czechia
Completed
Fakultni nemocnice BrnoBrno, 625 00, Czechia
Completed
Fakultni nemocnice Kralovske VinohradyPraha 10, 10034, Czechia
Withdrawn
Krajska Nemocnice LiberecLiberec, 460 63, Czechia
Completed
Saitama Sekishinkai HospitalSayama, 350-1305, Japan
Completed
Ogaki Municipal HospitalOgaki, 503-8502, Japan
Completed
Shin-Kuki General HospitalKuki, 346-8530, Japan
Completed
Chiba-Nishi General HospitalMatsudo, 270-2251, Japan
Completed
Tsukuba Medical Center HospitalTsukuba, 305-8558, Japan
Completed
Kishiwada Tokushukai HospitalKishiwada, 596-0042, Japan
Completed
Kokura Memorial HospitalKitakyushu, 802-8555, Japan
Completed
Hyogo Prefectural Harima-Himeji General Medical CenterHimeji, 670-8560, Japan
Completed
Saiseikai Kumamoto HospitalKumamoto, 861-4193, Japan
Completed
Oita Prefectural HospitalOita, 870-8511, Japan
Completed
Hokkaido Cardiovascular HospitalSapporo, 064-8622, Japan
Completed
Daido Hospital, Social Medical Corporation KojunkaiNagoya, 457-8511, Japan
Completed
Japanese Red Cross Fukuoka HospitalFukuoka, 815-8555, Japan
Withdrawn
Tsuchiura Kyodo General HospitalTsuchiura, 300-0028, Japan
Completed
Fukui Prefectural HospitalFukui, 910-8526, Japan
Completed
Tokyo Medical and Dental University HospitalBunkyo-ku, 113-8519, Japan
Completed
Bravis ZiekenhuisROOSENDAAL, 4708 AE, Netherlands
Completed
Gelre Ziekenhuizen ZutphenZUTPHEN, 7207 AE, Netherlands
Completed
Ikazia ZiekenhuisRotterdam, 3083 AN, Netherlands
Completed
Universitair Medisch Centrum St. RadboudNIJMEGEN, 6500 HB, Netherlands
Completed
Albert Schweitzer Ziekenhuis, DordwijkDORDRECHT, 3318 AT, Netherlands
Completed
Elkerliek Ziekenhuis, Lokatie HelmondHELMOND, 5707 HA, Netherlands
Completed
Reinier de Graaf GasthuisDELFT, 2625 AD, Netherlands
Completed
Jeroen Bosch ZiekenhuisDEN BOSCH, 5223 GZ, Netherlands
Completed
Canisius Wilhelmina ZiekenhuisNIJMEGEN, 6532 SZ, Netherlands
Completed
Zuyderland Medisch CentrumHEERLEN, 6419 PC, Netherlands
Completed
IsalaZwolle, 8025 AZ, Netherlands
Completed
Noord West Ziekenhuisgroep-Medisch Centrum AlkmaarALKMAAR, 1815 JD, Netherlands
Completed
Leids Universitair Medisch CentrumLEIDEN, 2333 ZA, Netherlands
Completed
VieCuri - Medisch Centrum voor Noord-Limburg locatie VenloVENLO, 5912 BL, Netherlands
Completed
Universitätsmedizin der Johannes Gutenberg Universität MainzMainz, 55131, Germany
Completed
Universitätsherzzentrum Freiburg - Bad KrozingenBad Krozingen, 79189, Germany
Completed
Kliniken Maria Hilf GmbHMönchengladbach, 41063, Germany
Completed
Universitätsklinikum EssenEssen, 45147, Germany
Completed
Universitätsklinikum Hamburg Eppendorf (UKE)Hamburg, 20246, Germany
Completed
St. Vinzenz-HospitalKöln, 50733, Germany
Completed
Forschungszentrum Ruhr - KliFoCenter GmbHWitten, 58455, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Completed
Krankenhaus Dresden-FriedrichstadtDresden, 01067, Germany
Completed
Kanagawa Cardiovascular and Respiratory CenterYokohama, 236-0051, Japan
Completed
Nishinomiya Watanabe Cardiovascular CenterNishinomiya, 662-0911, Japan
Completed
Fukuoka Tokushukai HospitalKasuga, 816-0864, Japan
Completed
Takahashi HospitalKobe, 654-0026, Japan
Completed
Hospital de la Santa Creu i de Sant Pau | CardiologíaBarcelona, 08041, Spain
Completed
Hospital Clinico Universitario Virgen de la Arrixaca | Neurology Department - StrokeMurcia, 30120, Spain
Completed
Hospital Universitario Virgen de las Nieves|CardiologiaGranada, 18014, Spain
Completed
Hospital Gral. Univ. de Valencia | CardiologiaValencia, 46014, Spain
Completed
Hospital Universitario Virgen de la MacarenaSevilla, 41071, Spain
Completed
Hospital Clinico Universitario San Carlos | CardiologiaMadrid, 28040, Spain
Completed
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Completed
Inst Investigacio Sanitaria Pere Virgili | Hosp Univ Joan XXIII de Tarragona - Neurology - Stroke, No-Cardioembolic-TiaTarragona, 43005, Spain
Completed
Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke PreventionBarcelona, 08907, Spain
Completed
Ciutat Sanitaria i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Hospital Ramon y Cajal | CardiologiaMadrid, 28034, Spain
Completed
Hospital Universitari i Politècnic La Fe | CardiologíaValencia, 46026, Spain
Withdrawn
Victoria Heart Institute FoundationVictoria, V8R 1B2, Canada
Withdrawn
Surrey Memorial HospitalSurrey, V3V 1Z2, Canada
Withdrawn
Edmonton Cardiology ConsultantEdmonton, T5H 3V9, Canada
Withdrawn
Hamilton General HospitalHamilton, L8L 2X2, Canada
Withdrawn
St. Michael's Hospital Health CentreToronto, M5B 1W8, Canada
Withdrawn
London Health Sciences CentreLondon, N6A 5A5, Canada
Withdrawn
University of Ottawa Heart InstituteOttawa, K1Y 4W7, Canada
Withdrawn
CHUM - Centre hospitalier de l'Université de MontréalMontreal, H2X 3H8, Canada
Withdrawn
Institute de Cardiologie de MontrealMontreal, H1T 1C8, Canada
Withdrawn
Hopital LavalQuebec, G6X 2H5, Canada
Withdrawn
York PCI Group Inc.Newmarket, L3Y 2P7, Canada
Completed
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza KorhazSzolnok, 5000, Hungary
Completed
Osaka General Medical CenterOsaka, 558-8558, Japan
Completed
Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi KrolowejRzeszow, 35-301, Poland
Withdrawn
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZBydgoszcz, 85-681, Poland
Completed
Sana-Klinikum Remscheid GmbHRemscheid, 42859, Germany
Completed
White Oak Medical CenterSilver Spring, 20904, United States
Completed
Clearwater Cardiovascular Associates | Clearwater, FLClearwater, 33756, United States
Completed
Florida Premier CardiologyBoyton Beach, 33437, United States
Withdrawn
Queen Elizabeth HospitalBirmingham, B15 2TH, United Kingdom
Completed
Wythenshawe HospitalManchester, M23 9LT, United Kingdom
Completed
Worcestershire Acute Hospital TrustWorcester, WR5 1DD, United Kingdom
Completed
Lister HospitalStevenage, SG1 4AB, United Kingdom
Completed
Freeman HospitalNewcastle Upon Tyne, NE7 7DN, United Kingdom
Completed
Imperial College LondonLondon, W12 0HS, United Kingdom
Completed
Southwest Florida ResearchNaples, 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 cause
    date_rangeTime Frame:
    From baseline up to 52 weeks
  • Safety - Number of participants with BARC bleeding definition type 2, 3 and 5
    Type 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 death
    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.
    date_rangeTime Frame:
    From baseline up to 52 weeks
  • Efficacy - Number of participants with MI
    Acute 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 stroke
    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.
    date_rangeTime Frame:
    From baseline up to 52 weeks
  • Efficacy - Number of participants with stent thrombosis
    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 cause
    date_rangeTime Frame:
    From baseline up to 52 weeks
  • Efficacy - Number of participants with all cause mortality
    date_rangeTime Frame:
    From baseline up to 52 weeks
  • Safety - Number of participants with all bleeding
    All bleeding events occurred from first intake of study intervention until 2 days after the last intake of study intervention
    date_rangeTime Frame:
    From baseline up to 52 weeks
  • Safety - Number of participants with BARC bleeding definition type 3, 5
    BARC 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 1,2,3,5
    Type 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

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