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
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
2 other identifiers
interventional
1,601
14 countries
160
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2020
160 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2020
CompletedFirst Posted
Study publicly available on registry
March 11, 2020
CompletedStudy Start
First participant enrolled
June 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2022
CompletedResults Posted
Study results publicly available
April 5, 2023
CompletedApril 5, 2023
April 1, 2023
1.7 years
March 8, 2020
February 19, 2023
April 3, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
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.
From baseline up to 52 weeks
Secondary Outcomes (8)
Efficacy - Number of Participants With CV Death
From baseline up to 52 weeks
Efficacy - Number of Participants With MI
From baseline up to 52 weeks
Efficacy - Number of Participants With Stroke
From baseline up to 52 weeks
Efficacy - Number of Participants With Stent Thrombosis
From baseline up to 52 weeks
Efficacy - Number of Participants With All Cause Mortality
From baseline up to 52 weeks
- +3 more secondary outcomes
Study Arms (4)
BAY 2433334 high dose
EXPERIMENTALBAY 2433334 medium dose
EXPERIMENTALBAY 2433334 low dose
EXPERIMENTALBAY2433334 matching placebo
PLACEBO COMPARATORInterventions
Tablet, taken orally once a day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (160)
Valley Clinical Trials, Inc. - Covina
Covina, California, 91723, United States
Florida Premier Cardiology
Boynton Beach, Florida, 33437, United States
Clearwater Cardiovascular Associates | Clearwater, FL
Clearwater, Florida, 33756, United States
Cardiology Associates Research Company
Daytona Beach, Florida, 32117, United States
Southwest Florida Research
Naples, Florida, 34102, United States
Cardiology Partners Clinical Research Institute
Palm Beach Gardens, Florida, 33410, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Reid Health
Richmond, Indiana, 47374, United States
Midwest Heart & Vascular Specialists
Overland Park, Kansas, 66211, United States
Cardiovascular Associates Research, LLC
Covington, Louisiana, 70433, United States
Southern Clinical Research, LLC
Zachary, Louisiana, 70791, United States
Maryland Cardiovascular Specialists
Baltimore, Maryland, 21229, United States
White Oak Medical Center
Silver Spring, Maryland, 20904, United States
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, 55805, United States
Logan Health Research
Kalispell, Montana, 59901, United States
Methodist Physicians Clinic
Omaha, Nebraska, 68114, United States
The Valley Hospital, Inc.
Ridgewood, New Jersey, 07450, United States
Trinity Medical WNY
Cheektowaga, New York, 14227, United States
Jefferson Heart Institute
Philadelphia, Pennsylvania, 19107, United States
Cardiovascular Research of Knoxville
Powell, Tennessee, 37849, United States
PharmaTex Research, LLC
Amarillo, Texas, 79109, United States
North Texas Research Associates
McKinney, Texas, 75071, United States
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Carinthia, 9020, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, Lower Austria, 3100, Austria
Landesklinikum Wiener Neustadt
Wiener Neustadt, Lower Austria, 2700, Austria
Medizinische Universität Graz
Graz, Styria, 8036, Austria
Krankenhaus St. Josef Braunau
Braunau am Inn, Upper Austria, 5280, Austria
Kepler Universitätsklinikum Campus III
Linz, Upper Austria, 4021, Austria
Universitätsklinikum AKH Wien
Vienna, 1090, Austria
Klinik Ottakring - Wilhelminenspital
Vienna, 1160, Austria
Klinik Floridsdorf - Krankenhaus Nord
Vienna, 1210, Austria
OL Vrouwziekenhuis - Campus Aalst
Aalst, 9300, Belgium
Imeldaziekenhuis - St-Elisabethkliniek
Bonheiden, 2820, Belgium
AZ Sint-Jan Brugge-Oostende | Sint-Jan - Cardiology
Bruges, 8000, Belgium
CU Saint-Luc/UZ St-Luc
Bruxelles - Brussel, 1200, Belgium
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
Jessa Ziekenhuis
Hasselt, 3500, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
CHR de la Citadelle - Cardiology
Liège, 4000, Belgium
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice u sv. Anny
Brno, 656 91, Czechia
Nemocnice Ceske Budejovice, a.s. Department of kardiologie
České Budějovice, 370 01, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Plzen - Lochotin
Pilsen, 304 60, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 10034, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 12808, Czechia
Institut Klinicke a Experimentalni Mediciny
Prague, 140 21, Czechia
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
Ustredni vojenska nemocnice Praha
Prague, 169 02, Czechia
Nemocnice Slany
Slaný, 274 01, Czechia
Universitätsherzzentrum Freiburg - Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, 79189, Germany
St. Vinzenz-Hospital
Cologne, North Rhine-Westphalia, 50733, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, North Rhine-Westphalia, 41063, Germany
Sana-Klinikum Remscheid GmbH
Remscheid, North Rhine-Westphalia, 42859, Germany
Forschungszentrum Ruhr - KliFoCenter GmbH
Witten, North Rhine-Westphalia, 58455, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Krankenhaus Dresden-Friedrichstadt
Dresden, Saxony, 01067, Germany
Universitätsklinikum Hamburg Eppendorf (UKE)
Hamburg, 20246, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Allami Szivkorhaz
Balatonfüred, 8230, Hungary
Budai Irgalmasrendi Korhaz
Budapest, 1023, Hungary
University of Semmelweis/ Semmelweis Egyetem
Budapest, 1122, Hungary
Eszak-Pesti Centrumkorhaz-Honvedkorhaz
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9023, Hungary
Pandy Kalman Korhaz
Gyula, 5700, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Josa Andras Hospital
Nyíregyháza, H-4400, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
Szolnok, 5000, Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, 8900, Hungary
A.O. San Pio
Benevento, Campania, 82100, Italy
ASL Caserta
Caserta, Campania, 81031, Italy
A.O.U. di Ferrara
Ferrara, Emilia-Romagna, 44124, Italy
Asl Roma 2
Rome, Lazio, 00157, Italy
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria, 16132, Italy
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
Milan, Lombardy, 20089, Italy
IRCCS Centro Cardiologico Monzino S.p.A
Milan, Lombardy, 20138, Italy
ASST Valle Olona
Varese, Lombardy, 21047, Italy
A.O. S.Croce e Carle
Cuneo, Piedmont, 12100, Italy
ASL TO3 di Collegno e Pinerolo
Turin, Piedmont, 10098, Italy
A.O.U. di Sassari
Sassari, Sardinia, Italy
A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
Ancona, The Marches, 60126, Italy
AUSL Toscana Sud-Est
Grosseto, Tuscany, 58100, Italy
ULSS3 Serenissima
Venezia, Veneto, 30035, Italy
Daido Hospital, Social Medical Corporation Kojunkai
Nagoya, Aichi-ken, 457-8511, Japan
Chiba-Nishi General Hospital
Matsudo, Chiba, 270-2251, Japan
Fukuoka Tokushukai Hospital
Kasuga, Fukuoka, 816-0864, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, 503-8502, Japan
Hokkaido Cardiovascular Hospital
Sapporo, Hokkaido, 064-8622, Japan
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji, Hyōgo, 670-8560, Japan
Takahashi Hospital
Kobe, Hyōgo, 654-0026, Japan
Nishinomiya Watanabe Cardiovascular Center
Nishinomiya, Hyōgo, 662-0911, Japan
Tsukuba Medical Center Hospital
Tsukuba, Ibaraki, 305-8558, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, 236-0051, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, 596-0042, Japan
Shin-Kuki General Hospital
Kukichūō, Saitama, 346-8530, Japan
Saitama Sekishinkai Hospital
Sayama, Saitama, 350-1305, Japan
Tokyo Medical and Dental University Hospital
Bunkyo-ku, Tokyo, 113-8519, Japan
Fukui Prefectural Hospital
Fukui, 910-8526, Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, 815-8555, Japan
Saiseikai Kumamoto Hospital
Kumamoto, 861-4193, Japan
Osaka General Medical Center
Osaka, 558-8558, Japan
Oita Prefectural Hospital
Ōita, 870-8511, Japan
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ, Netherlands
Noord West Ziekenhuisgroep-Medisch Centrum Alkmaar
Alkmaar, 1815 JD, Netherlands
Reinier de Graaf Gasthuis
Delft, 2625 AD, Netherlands
Albert Schweitzer Ziekenhuis, Dordwijk
Dordrecht, 3318 AT, Netherlands
Zuyderland Medisch Centrum
Heerlen, 6419 PC, Netherlands
Elkerliek Ziekenhuis, Lokatie Helmond
Helmond, 5707 HA, Netherlands
Leids Universitair Medisch Centrum
Leiden, 2333 ZA, Netherlands
Universitair Medisch Centrum St. Radboud
Nijmegen, 6500 HB, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, 6532 SZ, Netherlands
Bravis Ziekenhuis
Roosendaal, 4708 AE, Netherlands
Ikazia Ziekenhuis
Rotterdam, 3083 AN, Netherlands
VieCuri - Medisch Centrum voor Noord-Limburg locatie Venlo
Venlo, 5912 BL, Netherlands
Gelre Ziekenhuizen Zutphen
Zutphen, 7207 AE, Netherlands
Isala
Zwolle, 8025 AZ, Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276, Poland
Szpital sw. Wincentego a Paulo
Gdynia, 81-348, Poland
Samodzielny Publiczny Specjalistyczny Szpital Zachodni
Grodzisk Mazowiecki, 05-825, Poland
Uniwersytecki Szpital Kliniczny w Opolu
Opole, 45-401, Poland
Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej
Rzeszów, 35-301, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego UM
Warsaw, 02-097, Poland
Szpital Grochowski im. dr.med. Rafala Masztaka
Warsaw, 04-073, Poland
Uniwersytecki Szpital Kliniczny UM we Wroclawiu
Wroclaw, 50-556, Poland
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
Barcelona, 08035, Spain
Hospital de la Santa Creu i de Sant Pau | Cardiología
Barcelona, 08041, Spain
Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention
Barcelona, 08907, Spain
Hospital Universitario Virgen de las Nieves|Cardiologia
Granada, 18014, Spain
Hospital Ramon y Cajal | Cardiologia
Madrid, 28034, Spain
Hospital Clinico Universitario San Carlos | Cardiologia
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Clinico Universitario Virgen de la Arrixaca | Neurology Department - Stroke
Murcia, 30120, Spain
Hospital Universitario Virgen de la Macarena
Seville, 41071, Spain
Inst Investigacio Sanitaria Pere Virgili | Hosp Univ Joan XXIII de Tarragona - Neurology - Stroke, No-Cardioembolic-Tia
Tarragona, 43005, Spain
Hospital Gral. Univ. de Valencia | Cardiologia
Valencia, 46014, Spain
Hospital Universitari i Politècnic La Fe | Cardiología
Valencia, 46026, Spain
Falu Lasarett
Falun, 791 82, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Länssjukhuset Ryhov
Jönköping, 551 85, Sweden
Skånes Universitetssjukhus
Lund, 222 42, Sweden
Universitetssjukhuset Örebro
Örebro, 701 85, Sweden
Danderyds sjukhus
Stockholm, 182 88, Sweden
Länssjukhuset Sundsvall-Härnösand
Sundsvall, 851 86, Sweden
Akademiska sjukhuset Hjärtforskningsmottagningen
Uppsala, 751 85, Sweden
Västmanlands Sjukhus Västerås
Västerås, 721 89, Sweden
Kantonsspital Baselland - Standort Liestal
Liestal, Basel-Landschaft, 4410, Switzerland
Kantonsspital Aarau
Aarau, Canton of Aargau, 5001, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011, Switzerland
Kantonsspital Baden
Baden, 5404, Switzerland
Hôpital Cantonal Universitaire de Genève
Geneva, 1205, Switzerland
Luzerner Kantonsspital
Lucerne, 6000, Switzerland
Ospedale regionale di Lugano
Lugano, 6900, Switzerland
Lister Hospital
Stevenage, Hertfordshire, SG1 4AB, United Kingdom
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
Worcestershire Acute Hospital Trust
Worcester, Worcestershire, WR5 1DD, United Kingdom
Imperial College London
London, W12 0HS, United Kingdom
Wythenshawe Hospital
Manchester, M23 9LT, United Kingdom
Related Publications (2)
Whiteson HZ, Frishman WH. Factor XI/XIa Inhibitors: A New Approach to Anticoagulation. Cardiol Rev. 2025 Jul-Aug 01;33(4):306-311. doi: 10.1097/CRD.0000000000000624. Epub 2023 Dec 1.
PMID: 38038437DERIVEDRao SV, Kirsch B, Bhatt DL, Budaj A, Coppolecchia R, Eikelboom J, James SK, Jones WS, Merkely B, Keller L, Hermanides RS, Campo G, Ferreiro JL, Shibasaki T, Mundl H, Alexander JH; PACIFIC AMI Investigators. A Multicenter, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Trial of the Oral Factor XIa Inhibitor Asundexian to Prevent Adverse Cardiovascular Outcomes After Acute Myocardial Infarction. Circulation. 2022 Oct 18;146(16):1196-1206. doi: 10.1161/CIRCULATIONAHA.122.061612. Epub 2022 Aug 27.
PMID: 36030390DERIVED
Related Links
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer AG
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2020
First Posted
March 11, 2020
Study Start
June 17, 2020
Primary Completion
February 21, 2022
Study Completion
February 21, 2022
Last Updated
April 5, 2023
Results First Posted
April 5, 2023
Record last verified: 2023-04