Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack

NCT ID: NCT04304534

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1601 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-17
• Study Completion Date: 2022-02-21

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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BAY 2433334 high dose

Group Type: EXPERIMENTAL

BAY2433334

Intervention Type: DRUG

Tablet, taken orally once a day.

BAY 2433334 medium dose

Group Type: EXPERIMENTAL

BAY2433334

Intervention Type: DRUG

Tablet, taken orally once a day.

BAY 2433334 low dose

Group Type: EXPERIMENTAL

BAY2433334

Intervention Type: DRUG

Tablet, taken orally once a day.

BAY2433334 matching placebo

Group Type: PLACEBO_COMPARATOR

BAY2433334 matching placebo

Intervention Type: OTHER

Tablet, taken orally once a day.

Interventions

BAY2433334

Tablet, taken orally once a day.

Intervention Type: DRUG

BAY2433334 matching placebo

Tablet, taken orally once a day.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Valley Clinical Trials, Inc. - Covina

Covina, California, United States

Florida Premier Cardiology

Boynton Beach, Florida, United States

Clearwater Cardiovascular Associates | Clearwater, FL

Clearwater, Florida, United States

Cardiology Associates Research Company

Daytona Beach, Florida, United States

Southwest Florida Research

Naples, Florida, United States

Cardiology Partners Clinical Research Institute

Palm Beach Gardens, Florida, United States

Columbus Regional Research Institute

Columbus, Georgia, United States

Reid Health

Richmond, Indiana, United States

Midwest Heart & Vascular Specialists

Overland Park, Kansas, United States

Cardiovascular Associates Research, LLC

Covington, Louisiana, United States

Southern Clinical Research, LLC

Zachary, Louisiana, United States

Maryland Cardiovascular Specialists

Baltimore, Maryland, United States

White Oak Medical Center

Silver Spring, Maryland, United States

St. Mary's/Duluth Clinic Health System

Duluth, Minnesota, United States

Logan Health Research

Kalispell, Montana, United States

Methodist Physicians Clinic

Omaha, Nebraska, United States

The Valley Hospital, Inc.

Ridgewood, New Jersey, United States

Trinity Medical WNY

Cheektowaga, New York, United States

Jefferson Heart Institute

Philadelphia, Pennsylvania, United States

Cardiovascular Research of Knoxville

Powell, Tennessee, United States

PharmaTex Research, LLC

Amarillo, Texas, United States

North Texas Research Associates

McKinney, Texas, United States

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Carinthia, Austria

Universitätsklinikum St. Pölten

Sankt Pölten, Lower Austria, Austria

Landesklinikum Wiener Neustadt

Wiener Neustadt, Lower Austria, Austria

Medizinische Universität Graz

Graz, Styria, Austria

Krankenhaus St. Josef Braunau

Braunau am Inn, Upper Austria, Austria

Kepler Universitätsklinikum Campus III

Linz, Upper Austria, Austria

Universitätsklinikum AKH Wien

Vienna, , Austria

Klinik Ottakring - Wilhelminenspital

Vienna, , Austria

Klinik Floridsdorf - Krankenhaus Nord

Vienna, , Austria

OL Vrouwziekenhuis - Campus Aalst

Aalst, , Belgium

Imeldaziekenhuis - St-Elisabethkliniek

Bonheiden, , Belgium

AZ Sint-Jan Brugge-Oostende | Sint-Jan - Cardiology

Bruges, , Belgium

CU Saint-Luc/UZ St-Luc

Bruxelles - Brussel, , Belgium

Ziekenhuis Oost-Limburg

Genk, , Belgium

Jessa Ziekenhuis

Hasselt, , Belgium

UZ Leuven Gasthuisberg

Leuven, , Belgium

CHR de la Citadelle - Cardiology

Liège, , Belgium

Fakultni nemocnice Brno

Brno, , Czechia

Fakultni nemocnice u sv. Anny

Brno, , Czechia

Nemocnice Ceske Budejovice, a.s. Department of kardiologie

České Budějovice, , Czechia

Fakultni Nemocnice Hradec Kralove

Hradec Králové, , Czechia

Fakultni nemocnice Plzen - Lochotin

Pilsen, , Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

Institut Klinicke a Experimentalni Mediciny

Prague, , Czechia

Fakultni nemocnice v Motole

Prague, , Czechia

Ustredni vojenska nemocnice Praha

Prague, , Czechia

Nemocnice Slany

Slaný, , Czechia

Universitätsherzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, Germany

St. Vinzenz-Hospital

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Kliniken Maria Hilf GmbH

Mönchengladbach, North Rhine-Westphalia, Germany

Sana-Klinikum Remscheid GmbH

Remscheid, North Rhine-Westphalia, Germany

Forschungszentrum Ruhr - KliFoCenter GmbH

Witten, North Rhine-Westphalia, Germany

Universitätsmedizin der Johannes Gutenberg Universität Mainz

Mainz, Rhineland-Palatinate, Germany

Krankenhaus Dresden-Friedrichstadt

Dresden, Saxony, Germany

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Allami Szivkorhaz

Balatonfüred, , Hungary

Budai Irgalmasrendi Korhaz

Budapest, , Hungary

University of Semmelweis/ Semmelweis Egyetem

Budapest, , Hungary

Eszak-Pesti Centrumkorhaz-Honvedkorhaz

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Pandy Kalman Korhaz

Gyula, , Hungary

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, , Hungary

Josa Andras Hospital

Nyíregyháza, , Hungary

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

Szolnok, , Hungary

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, , Hungary

A.O. San Pio

Benevento, Campania, Italy

ASL Caserta

Caserta, Campania, Italy

A.O.U. di Ferrara

Ferrara, Emilia-Romagna, Italy

Asl Roma 2

Rome, Lazio, Italy

IRCCS Ospedale Policlinico San Martino

Genoa, Liguria, Italy

Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

Milan, Lombardy, Italy

IRCCS Centro Cardiologico Monzino S.p.A

Milan, Lombardy, Italy

ASST Valle Olona

Varese, Lombardy, Italy

A.O. S.Croce e Carle

Cuneo, Piedmont, Italy

ASL TO3 di Collegno e Pinerolo

Turin, Piedmont, Italy

A.O.U. di Sassari

Sassari, Sardinia, Italy

A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"

Ancona, The Marches, Italy

AUSL Toscana Sud-Est

Grosseto, Tuscany, Italy

ULSS3 Serenissima

Venezia, Veneto, Italy

Daido Hospital, Social Medical Corporation Kojunkai

Nagoya, Aichi-ken, Japan

Chiba-Nishi General Hospital

Matsudo, Chiba, Japan

Fukuoka Tokushukai Hospital

Kasuga, Fukuoka, Japan

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Ogaki Municipal Hospital

Ōgaki, Gifu, Japan

Hokkaido Cardiovascular Hospital

Sapporo, Hokkaido, Japan

Hyogo Prefectural Harima-Himeji General Medical Center

Himeji, Hyōgo, Japan

Takahashi Hospital

Kobe, Hyōgo, Japan

Nishinomiya Watanabe Cardiovascular Center

Nishinomiya, Hyōgo, Japan

Tsukuba Medical Center Hospital

Tsukuba, Ibaraki, Japan

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa, Japan

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, Japan

Shin-Kuki General Hospital

Kukichūō, Saitama, Japan

Saitama Sekishinkai Hospital

Sayama, Saitama, Japan

Tokyo Medical and Dental University Hospital

Bunkyo-ku, Tokyo, Japan

Fukui Prefectural Hospital

Fukui, , Japan

Japanese Red Cross Fukuoka Hospital

Fukuoka, , Japan

Saiseikai Kumamoto Hospital

Kumamoto, , Japan

Osaka General Medical Center

Osaka, , Japan

Oita Prefectural Hospital

Ōita, , Japan

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Noord West Ziekenhuisgroep-Medisch Centrum Alkmaar

Alkmaar, , Netherlands

Reinier de Graaf Gasthuis

Delft, , Netherlands

Albert Schweitzer Ziekenhuis, Dordwijk

Dordrecht, , Netherlands

Zuyderland Medisch Centrum

Heerlen, , Netherlands

Elkerliek Ziekenhuis, Lokatie Helmond

Helmond, , Netherlands

Leids Universitair Medisch Centrum

Leiden, , Netherlands

Universitair Medisch Centrum St. Radboud

Nijmegen, , Netherlands

Canisius Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Bravis Ziekenhuis

Roosendaal, , Netherlands

Ikazia Ziekenhuis

Rotterdam, , Netherlands

VieCuri - Medisch Centrum voor Noord-Limburg locatie Venlo

Venlo, , Netherlands

Gelre Ziekenhuizen Zutphen

Zutphen, , Netherlands

Isala

Zwolle, , Netherlands

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, , Poland

Szpital sw. Wincentego a Paulo

Gdynia, , Poland

Samodzielny Publiczny Specjalistyczny Szpital Zachodni

Grodzisk Mazowiecki, , Poland

Uniwersytecki Szpital Kliniczny w Opolu

Opole, , Poland

Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej

Rzeszów, , Poland

Uniwersyteckie Centrum Kliniczne Warszawskiego UM

Warsaw, , Poland

Szpital Grochowski im. dr.med. Rafala Masztaka

Warsaw, , Poland

Uniwersytecki Szpital Kliniczny UM we Wroclawiu

Wroclaw, , Poland

Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Barcelona, , Spain

Hospital de la Santa Creu i de Sant Pau | Cardiología

Barcelona, , Spain

Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention

Barcelona, , Spain

Hospital Universitario Virgen de las Nieves|Cardiologia

Granada, , Spain

Hospital Ramon y Cajal | Cardiologia

Madrid, , Spain

Hospital Clinico Universitario San Carlos | Cardiologia

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Clinico Universitario Virgen de la Arrixaca | Neurology Department - Stroke

Murcia, , Spain

Hospital Universitario Virgen de la Macarena

Seville, , Spain

Inst Investigacio Sanitaria Pere Virgili | Hosp Univ Joan XXIII de Tarragona - Neurology - Stroke, No-Cardioembolic-Tia

Tarragona, , Spain

Hospital Gral. Univ. de Valencia | Cardiologia

Valencia, , Spain

Hospital Universitari i Politècnic La Fe | Cardiología

Valencia, , Spain

Falu Lasarett

Falun, , Sweden

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Länssjukhuset Ryhov

Jönköping, , Sweden

Skånes Universitetssjukhus

Lund, , Sweden

Universitetssjukhuset Örebro

Örebro, , Sweden

Danderyds sjukhus

Stockholm, , Sweden

Länssjukhuset Sundsvall-Härnösand

Sundsvall, , Sweden

Akademiska sjukhuset Hjärtforskningsmottagningen

Uppsala, , Sweden

Västmanlands Sjukhus Västerås

Västerås, , Sweden

Kantonsspital Baselland - Standort Liestal

Liestal, Basel-Landschaft, Switzerland

Kantonsspital Aarau

Aarau, Canton of Aargau, Switzerland

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Kantonsspital Baden

Baden, , Switzerland

Hôpital Cantonal Universitaire de Genève

Geneva, , Switzerland

Luzerner Kantonsspital

Lucerne, , Switzerland

Ospedale regionale di Lugano

Lugano, , Switzerland

Lister Hospital

Stevenage, Hertfordshire, United Kingdom

Freeman Hospital

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Worcestershire Acute Hospital Trust

Worcester, Worcestershire, United Kingdom

Imperial College London

London, , United Kingdom

Wythenshawe Hospital

Manchester, , United Kingdom

Countries

United States; Austria; Belgium; Czechia; Germany; Hungary; Italy; Japan; Netherlands; Poland; Spain; Sweden; Switzerland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 38038437 (View on PubMed)

Rao 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.

Reference Type: DERIVED

PMID: 36030390 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

2019-003244-79

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20603

Identifier Type: -

Identifier Source: org_study_id