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:

NCT04304534

EudraCT Number:

2019-003244-79

Study Completed

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
1592
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Asundexian (BAY2433334)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Reid Health

Richmond, United States, 47374

Status
Completed
 
Locations

Cardiology Associates Research Company

Daytona Beach, United States, 32117

Status
Completed
 
Locations

Cardiovascular Research of Knoxville

Powell, United States, 37849

Status
Completed
 
Locations

PharmaTex Research, LLC

Amarillo, United States, 79109

Status
Completed
 
Locations

Krankenhaus St. Josef Braunau

Braunau, Austria, 5280

Status
Completed
 
Locations

Universitätsklinikum St. Pölten

St. Pölten, Austria, 3100

Status
Completed
 
Locations

Klinik Floridsdorf - Krankenhaus Nord

Wien, Austria, 1210

Status
Completed
 
Locations

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Austria, 9020

Status
Completed
 
Locations

Klinik Ottakring - Wilhelminenspital

Wien, Austria, 1160

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Universitätsklinikum AKH Wien

Wien, Austria, 1090

Status
Completed
 
Locations

Landesklinikum Wiener Neustadt

Wiener Neustadt, Austria, 2700

Status
Completed
 
Locations

Kepler Universitätsklinikum Campus III

Linz, Austria, 4021

Status
Completed
 
Locations

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

Milano, Italy, 20089

Status
Completed
 
Locations

IRCCS Centro Cardiologico Monzino

Milano, Italy, 20138

Status
Completed
 
Locations

ASL TO3 di Collegno e Pinerolo

Torino, Italy, 10098

Status
Completed
 
Locations

A.O.U. di Ferrara

Ferrara, Italy, 44124

Status
Completed
 
Locations

ASST Valle Olona

Varese, Italy, 21047

Status
Completed
 
Locations

IRCCS Ospedale Policlinico San Martino

Genova, Italy, 16132

Status
Completed
 
Locations

ASL Caserta

Caserta, Italy, 81031

Status
Completed
 
Locations

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

Ancona, Italy, 60126

Status
Completed
 
Locations

ASL ROMA 2

Roma, Italy, 00157

Status
Completed
 
Locations

ULSS3 Serenissima

Venezia, Italy, 30035

Status
Completed
 
Locations

A.O. San Pio

Benevento, Italy, 82100

Status
Completed
 
Locations

A.O. S.Croce e Carle

Cuneo, Italy, 12100

Status
Completed
 
Locations

A.O.U. di Sassari

Sassari, Italy

Status
Completed
 
Locations

AUSL Toscana Sud-Est

Grosseto, Italy, 58100

Status
Completed
 
Locations

Southern Clinical Research, LLC

Zachary, United States, 70791

Status
Completed
 
Locations

Cardiovascular Associates Research, LLC

Covington, United States, 70433

Status
Completed
 
Locations

St. Mary's/Duluth Clinic Health System

Duluth, United States, 55805

Status
Completed
 
Locations

Columbus Regional Research Institute

Columbus, United States, 31904

Status
Completed
 
Locations

Midwest Heart & Vascular Specialists

Overland Park, United States, 66211

Status
Completed
 
Locations

North Texas Research Associates

McKinney, United States, 75071

Status
Completed
 
Locations

Methodist Physicians Clinic

Omaha, United States, 68114

Status
Completed
 
Locations

Trinity Medical WNY

Cheektowaga, United States, 14227

Status
Completed
 
Locations

Valley Clinical Trials, Inc.

Covina, United States, 91723

Status
Completed
 
Locations

Cardiology Partners Clinical Research Institute

Palm Beach Gardens, United States, 33410

Status
Completed
 
Locations

Jefferson Heart Institute

Philadelphia, United States, 19107

Status
Completed
 
Locations

Logan Health Research

Kalispell, United States, 59901

Status
Completed
 
Locations

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland, 1011

Status
Completed
 
Locations

Hôpital Cantonal Universitaire de Genève

Genève, Switzerland, 1205

Status
Completed
 
Locations

Ospedale regionale di Lugano

Lugano, Switzerland, 6900

Status
Completed
 
Locations

Luzerner Kantonsspital

Luzern, Switzerland, 6000

Status
Completed
 
Locations

Kantonsspital Aarau

Aarau, Switzerland, 5001

Status
Completed
 
Locations

Kantonsspital Baselland - Standort Liestal

Liestal, Switzerland, 4410

Status
Completed
 
Locations

Kantonsspital Baden

Baden, Switzerland, 5404

Status
Completed
 
Locations

Maryland Cardiovascular Specialists

Baltimore, United States, 21229

Status
Completed
 
Locations

The Valley Hospital, Inc.

Ridgewood, United States, 07450

Status
Completed
 
Locations

Szpital Grochowski im. dr.med. Rafala Masztaka

Warszawa, Poland, 04-073

Status
Completed
 
Locations

Szpital sw. Wincentego a Paulo

Gdynia, Poland, 81-348

Status
Completed
 
Locations

Uniwersytecki Szpital Kliniczny UM we Wroclawiu

Wroclaw, Poland, 50-556

Status
Completed
 
Locations

Uniwersyteckie Centrum Kliniczne Warszawskiego UM

Warszawa, Poland, 02-097

Status
Completed
 
Locations

Uniwersytecki Szpital Kliniczny w Opolu

Opole, Poland, 45-401

Status
Completed
 
Locations

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland, 15-276

Status
Completed
 
Locations

Samodzielny Publiczny Specjalistyczny Szpital Zachodni

Grodzisk Mazowiecki, Poland, 05-825

Status
Completed
 
Locations

Ziekenhuis Oost-Limburg

GENK, Belgium, 3600

Status
Completed
 
Locations

AZ St-Jan Brugge Oostende AV

BRUGGE, Belgium, 8000

Status
Completed
 
Locations

OL Vrouwziekenhuis - Campus Aalst

AALST, Belgium, 9300

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 413 45

Status
Completed
 
Locations

Danderyds sjukhus

Stockholm, Sweden, 182 88

Status
Completed
 
Locations

Länssjukhuset Ryhov

Jönköping, Sweden, 551 85

Status
Completed
 
Locations

Skånes Universitetssjukhus

Lund, Sweden, 222 42

Status
Completed
 
Locations

Falu Lasarett

Falun, Sweden, 791 82

Status
Completed
 
Locations

Akademiska Sjukhuset

Uppsala, Sweden, 751 85

Status
Completed
 
Locations

Länssjukhuset Sundsvall-Härnösand

Sundsvall, Sweden, 851 86

Status
Completed
 
Locations

Västmanlands Sjukhus Västerås

Västerås, Sweden, 721 89

Status
Completed
 
Locations

Universitetssjukhuset Örebro

Örebro, Sweden, 701 85

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Imeldaziekenhuis - St-Elisabethkliniek

BONHEIDEN, Belgium, 2820

Status
Completed
 
Locations

Jessa Ziekenhuis

HASSELT, Belgium, 3500

Status
Completed
 
Locations

CHR de la Citadelle

LIEGE, Belgium, 4000

Status
Completed
 
Locations

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Status
Completed
 
Locations

Petz Aladar Megyei Oktato Korhaz

Gyor, Hungary, 9023

Status
Completed
 
Locations

Allami Szivkorhaz

Balatonfured, Hungary, 8230

Status
Completed
 
Locations

Pandy Kalman Korhaz

Gyula, Hungary, 5700

Status
Completed
 
Locations

Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz

Budapest, Hungary

Status
Completed
 
Locations

Josa Andras Hospital

Nyiregyhaza, Hungary, H-4400

Status
Completed
 
Locations

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, Hungary, 8900

Status
Completed
 
Locations

University of Semmelweis/ Semmelweis Egyetem

Budapest, Hungary, 1122

Status
Completed
 
Locations

Budai Irgalmasrendi Korhaz

Budapest, Hungary, 1023

Status
Completed
 
Locations

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvar, Hungary, 7400

Status
Completed
 
Locations

Nemocnice Slany

Slany, Czech Republic, 274 01

Status
Completed
 
Locations

Fakultni nemocnice u sv. Anny

Brno, Czech Republic, 656 91

Status
Completed
 
Locations

Institut Klinicke a Experimentalni Mediciny

Praha 4, Czech Republic, 140 21

Status
Completed
 
Locations

Fakultni nemocnice Plzen

Plzen, Czech Republic, 304 60

Status
Completed
 
Locations

Vseobecna fakultni nemocnice v Praze

Praha 2, Czech Republic, 12808

Status
Completed
 
Locations

Fakultni nemocnice v Motole

Praha 5, Czech Republic, 150 06

Status
Completed
 
Locations

Nemocnice Ceske Budejovice, a.s.

Ceske Budejovice, Czech Republic, 370 01

Status
Completed
 
Locations

Fakultni Nemocnice Hradec Kralove

Hradec Kralove, Czech Republic, 500 05

Status
Completed
 
Locations

Ustredni vojenska nemocnice Praha

Praha 6, Czech Republic, 169 02

Status
Completed
 
Locations

Fakultni nemocnice Brno

Brno, Czech Republic, 625 00

Status
Completed
 
Locations

Fakultni nemocnice Kralovske Vinohrady

Praha 10, Czech Republic, 10034

Status
Completed
 
Locations

Saitama Sekishinkai Hospital

Sayama, Japan, 350-1305

Status
Completed
 
Locations

Ogaki Municipal Hospital

Ogaki, Japan, 503-8502

Status
Completed
 
Locations

Shin-Kuki General Hospital

Kuki, Japan, 346-8530

Status
Completed
 
Locations

Chiba-Nishi General Hospital

Matsudo, Japan, 270-2251

Status
Completed
 
Locations

Tsukuba Medical Center Hospital

Tsukuba, Japan, 305-8558

Status
Completed
 
Locations

Kishiwada Tokushukai Hospital

Kishiwada, Japan, 596-0042

Status
Completed
 
Locations

Kokura Memorial Hospital

Kitakyushu, Japan, 802-8555

Status
Completed
 
Locations

Hyogo Brain and Heart Center

Himeji, Japan, 670-0981

Status
Completed
 
Locations

Saiseikai Kumamoto Hospital

Kumamoto, Japan, 861-4193

Status
Completed
 
Locations

Oita Prefectural Hospital

Oita, Japan, 870-8511

Status
Completed
 
Locations

Hokkaido Cardiovascular Hospital

Sapporo, Japan, 064-8622

Status
Completed
 
Locations

Daido Hospital, Social Medical Corporation Kojunkai

Nagoya, Japan, 457-8511

Status
Completed
 
Locations

Japanese Red Cross Fukuoka Hospital

Fukuoka, Japan, 815-8555

Status
Completed
 
Locations

Fukui Prefectural Hospital

Fukui, Japan, 910-8526

Status
Completed
 
Locations

Tokyo Medical and Dental University Hospital

Bunkyo-ku, Japan, 113-8519

Status
Completed
 
Locations

Bravis Ziekenhuis

ROOSENDAAL, Netherlands, 4708 AE

Status
Completed
 
Locations

Gelre Ziekenhuizen Zutphen

Zutphen, Netherlands, 7207 AE

Status
Completed
 
Locations

Ikazia Ziekenhuis

ROTTERDAM, Netherlands, 3083 AN

Status
Completed
 
Locations

Universitair Medisch Centrum St. Radboud

NIJMEGEN, Netherlands, 6525 GA

Status
Completed
 
Locations

Albert Schweitzer Ziekenhuis, Locatie Dordwijk

DORDRECHT, Netherlands, 3318 AT

Status
Completed
 
Locations

Elkerliek Ziekenhuis, Lokatie Helmond

HELMOND, Netherlands, 5707 HA

Status
Completed
 
Locations

Reinier de Graaf Gasthuis

DELFT, Netherlands, 2625 AD

Status
Completed
 
Locations

Jeroen Bosch Ziekenhuis

DEN BOSCH, Netherlands, 5223 GZ

Status
Completed
 
Locations

Canisius Wilhelmina Ziekenhuis

NIJMEGEN, Netherlands, 6532 SZ

Status
Completed
 
Locations

Zuyderland Medisch Centrum

HEERLEN, Netherlands, 6401 CX

Status
Completed
 
Locations

Isala

ZWOLLE, Netherlands, 8025 AB

Status
Completed
 
Locations

Noord West Ziekenhuisgroep-Medisch Centrum Alkmaar

ALKMAAR, Netherlands, 1815 JD

Status
Completed
 
Locations

Leids Universitair Medisch Centrum

LEIDEN, Netherlands, 2333 ZA

Status
Completed
 
Locations

VieCuri - Medisch Centrum voor Noord-Limburg locatie Venlo

VENLO, Netherlands, 5912 BL

Status
Completed
 
Locations

Universitätsmedizin der Johannes Gutenberg Universität Mainz

Mainz, Germany, 55131

Status
Completed
 
Locations

Universitätsherzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany, 79189

Status
Completed
 
Locations

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany, 41063

Status
Completed
 
Locations

Universitätsklinikum Essen

Essen, Germany, 45147

Status
Completed
 
Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

Status
Completed
 
Locations

St. Vinzenz-Hospital

Köln, Germany, 50733

Status
Completed
 
Locations

Forschungszentrum Ruhr - KliFoCenter GmbH

Witten, Germany, 58455

Status
Completed
 
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Status
Completed
 
Locations

Krankenhaus Dresden-Friedrichstadt

Dresden, Germany, 01067

Status
Completed
 
Locations

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Japan, 236-0051

Status
Completed
 
Locations

Nishinomiya Watanabe Cardiovascular Center

Nishinomiya, Japan, 662-0911

Status
Completed
 
Locations

Fukuoka Tokushukai Hospital

Kasuga, Japan, 816-0864

Status
Completed
 
Locations

Takahashi Hospital

Kobe, Japan, 654-0026

Status
Completed
 
Locations

Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08041

Status
Completed
 
Locations

Hospital Universitario "Virgen de la Arrixaca"

El Palmar (Murcia), Spain, 30120

Status
Completed
 
Locations

Hospital Universitario Virgen de las Nieves

Granada, Spain, 18014

Status
Completed
 
Locations

Hospital Álvaro Cunqueiro

Babio - Beade, Spain, 36312

Status
Completed
 
Locations

Hospital Universitario Virgen de la Macarena

Sevilla, Spain, 41071

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
 
Locations

Hospital Joan XXIII

Tarragona, Spain, 43005

Status
Completed
 
Locations

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Hospital Ramón y Cajal

Madrid, Spain, 28034

Status
Completed
 
Locations

Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

Status
Completed
 
Locations

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

Szolnok, Hungary, 5000

Status
Completed
 
Locations

Osaka General Medical Center

Osaka, Japan, 558-8558

Status
Completed
 
Locations

Szpital Wojewodzki Nr 2

Rzeszow, Poland, 35-301

Status
Completed
 
Locations

Sana-Klinikum Remscheid GmbH

Remscheid, Germany, 42859

Status
Completed
 
Locations

White Oak Medical Center

Silver Spring, United States, 20904

Status
Completed
 
Locations

Clearwater Cardiovascular & Interventional Cons - Clearwater

Clearwater, United States, 33756

Status
Completed
 
Locations

Florida Premier Cardiology

Boyton Beach, United States, 33437

Status
Completed
 
Locations

Wythenshawe Hospital

Manchester, United Kingdom, M23 9LT

Status
Completed
 
Locations

Worcestershire Acute Hospital Trust

Worcester, United Kingdom, WR5 1DD

Status
Completed
 
Locations

Lister Hospital

Stevenage, United Kingdom, SG1 4AB

Status
Completed
 
Locations

Freeman Hospital

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Status
Completed
 
Locations

Imperial College London

London, United Kingdom, W12 0HS

Status
Completed
 
Locations

Southwest Florida Research

Naples, United States, 34102

Status
Completed
 

Trial Design