AzTrials
AzTrials

Acute Myocardial InfarctionPhase 2PACIFIC-AMINCT04304534

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

A Phase 2 study testing BAY2433334 in people with Acute Myocardial Infarction, run by Bayer at 160 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
BAY2433334
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,601 participants
Where
160 sitesin 14 countries
Study dates
17 Jun 2020to 21 Feb 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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.

Who cannot join

  • 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 locations and contacts

160 sites in 14 countries.

160 sites in 14 countries

United States22 sites

  • PharmaTex Research, LLC

    Amarillo, Texas, 79109

  • Maryland Cardiovascular Specialists

    Baltimore, Maryland, 21229

  • Florida Premier Cardiology

    Boynton Beach, Florida, 33437

  • Trinity Medical WNY

    Cheektowaga, New York, 14227

  • Clearwater Cardiovascular Associates | Clearwater, FL

    Clearwater, Florida, 33756

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Valley Clinical Trials, Inc. - Covina

    Covina, California, 91723

  • Cardiovascular Associates Research, LLC

    Covington, Louisiana, 70433

  • Cardiology Associates Research Company

    Daytona Beach, Florida, 32117

  • St. Mary's/Duluth Clinic Health System

    Duluth, Minnesota, 55805

  • Logan Health Research

    Kalispell, Montana, 59901

  • North Texas Research Associates

    McKinney, Texas, 75071

  • Southwest Florida Research

    Naples, Florida, 34102

  • Methodist Physicians Clinic

    Omaha, Nebraska, 68114

  • Midwest Heart & Vascular Specialists

    Overland Park, Kansas, 66211

  • Cardiology Partners Clinical Research Institute

    Palm Beach Gardens, Florida, 33410

  • Jefferson Heart Institute

    Philadelphia, Pennsylvania, 19107

  • Cardiovascular Research of Knoxville

    Powell, Tennessee, 37849

  • Reid Health

    Richmond, Indiana, 47374

  • The Valley Hospital, Inc.

    Ridgewood, New Jersey, 07450

  • White Oak Medical Center

    Silver Spring, Maryland, 20904

  • Southern Clinical Research, LLC

    Zachary, Louisiana, 70791

Other trials in United States

Japan20 sites

  • Tokyo Medical and Dental University Hospital

    Bunkyo-ku, Tokyo, 113-8519

  • Fukui Prefectural Hospital

    Fukui, 910-8526

  • Japanese Red Cross Fukuoka Hospital

    Fukuoka, 815-8555

  • Hyogo Prefectural Harima-Himeji General Medical Center

    Himeji, Hyōgo, 670-8560

  • Fukuoka Tokushukai Hospital

    Kasuga, Fukuoka, 816-0864

  • Kishiwada Tokushukai Hospital

    Kishiwada, Osaka, 596-0042

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555

  • Takahashi Hospital

    Kobe, Hyōgo, 654-0026

  • Shin-Kuki General Hospital

    Kukichūō, Saitama, 346-8530

  • Saiseikai Kumamoto Hospital

    Kumamoto, 861-4193

  • Chiba-Nishi General Hospital

    Matsudo, Chiba, 270-2251

  • Daido Hospital, Social Medical Corporation Kojunkai

    Nagoya, Aichi-ken, 457-8511

  • Nishinomiya Watanabe Cardiovascular Center

    Nishinomiya, Hyōgo, 662-0911

  • Ogaki Municipal Hospital

    Ōgaki, Gifu, 503-8502

  • Oita Prefectural Hospital

    Ōita, 870-8511

  • Osaka General Medical Center

    Osaka, 558-8558

  • Hokkaido Cardiovascular Hospital

    Sapporo, Hokkaido, 064-8622

  • Saitama Sekishinkai Hospital

    Sayama, Saitama, 350-1305

  • Tsukuba Medical Center Hospital

    Tsukuba, Ibaraki, 305-8558

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, Kanagawa, 236-0051

Other trials in Japan

Italy14 sites

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

    Ancona, The Marches, 60126

  • A.O. San Pio

    Benevento, Campania, 82100

  • ASL Caserta

    Caserta, Campania, 81031

  • A.O. S.Croce e Carle

    Cuneo, Piedmont, 12100

  • A.O.U. di Ferrara

    Ferrara, Emilia-Romagna, 44124

  • IRCCS Ospedale Policlinico San Martino

    Genoa, Liguria, 16132

  • AUSL Toscana Sud-Est

    Grosseto, Tuscany, 58100

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

    Milan, Lombardy, 20089

  • IRCCS Centro Cardiologico Monzino S.p.A

    Milan, Lombardy, 20138

  • Asl Roma 2

    Rome, Lazio, 00157

  • A.O.U. di Sassari

    Sassari, Sardinia

  • ASL TO3 di Collegno e Pinerolo

    Turin, Piedmont, 10098

  • ASST Valle Olona

    Varese, Lombardy, 21047

  • ULSS3 Serenissima

    Venezia, Veneto, 30035

Other trials in Italy

Netherlands14 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ

  • Noord West Ziekenhuisgroep-Medisch Centrum Alkmaar

    Alkmaar, 1815 JD

  • Reinier de Graaf Gasthuis

    Delft, 2625 AD

  • Albert Schweitzer Ziekenhuis, Dordwijk

    Dordrecht, 3318 AT

  • Zuyderland Medisch Centrum

    Heerlen, 6419 PC

  • Elkerliek Ziekenhuis, Lokatie Helmond

    Helmond, 5707 HA

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA

  • Universitair Medisch Centrum St. Radboud

    Nijmegen, 6500 HB

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen, 6532 SZ

  • Bravis Ziekenhuis

    Roosendaal, 4708 AE

  • Ikazia Ziekenhuis

    Rotterdam, 3083 AN

  • VieCuri - Medisch Centrum voor Noord-Limburg locatie Venlo

    Venlo, 5912 BL

  • Gelre Ziekenhuizen Zutphen

    Zutphen, 7207 AE

  • Isala

    Zwolle, 8025 AZ

Other trials in Netherlands

Spain12 sites

  • Ciutat Sanitaria i Universitaria de la Vall d'Hebron

    Barcelona, 08035

  • Hospital de la Santa Creu i de Sant Pau | Cardiología

    Barcelona, 08041

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

    Barcelona, 08907

  • Hospital Universitario Virgen de las Nieves|Cardiologia

    Granada, 18014

  • Hospital Ramon y Cajal | Cardiologia

    Madrid, 28034

  • Hospital Clinico Universitario San Carlos | Cardiologia

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

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

    Murcia, 30120

  • Hospital Universitario Virgen de la Macarena

    Seville, 41071

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

    Tarragona, 43005

  • Hospital Gral. Univ. de Valencia | Cardiologia

    Valencia, 46014

  • Hospital Universitari i Politècnic La Fe | Cardiología

    Valencia, 46026

Other trials in Spain

Czechia11 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice u sv. Anny

    Brno, 656 91

  • Nemocnice Ceske Budejovice, a.s. Department of kardiologie

    České Budějovice, 370 01

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Plzen - Lochotin

    Pilsen, 304 60

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808

  • Institut Klinicke a Experimentalni Mediciny

    Prague, 140 21

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • Ustredni vojenska nemocnice Praha

    Prague, 169 02

  • Nemocnice Slany

    Slaný, 274 01

Other trials in Czechia

Hungary11 sites

  • Allami Szivkorhaz

    Balatonfüred, 8230

  • Budai Irgalmasrendi Korhaz

    Budapest, 1023

  • University of Semmelweis/ Semmelweis Egyetem

    Budapest, 1122

  • Eszak-Pesti Centrumkorhaz-Honvedkorhaz

    Budapest

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9023

  • Pandy Kalman Korhaz

    Gyula, 5700

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400

  • Josa Andras Hospital

    Nyíregyháza, H-4400

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

    Szolnok, 5000

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

Germany10 sites

  • Universitätsherzzentrum Freiburg - Bad Krozingen

    Bad Krozingen, Baden-Wurttemberg, 79189

  • St. Vinzenz-Hospital

    Cologne, North Rhine-Westphalia, 50733

  • Krankenhaus Dresden-Friedrichstadt

    Dresden, Saxony, 01067

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • Universitätsklinikum Hamburg Eppendorf (UKE)

    Hamburg, 20246

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsmedizin der Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, North Rhine-Westphalia, 41063

  • Sana-Klinikum Remscheid GmbH

    Remscheid, North Rhine-Westphalia, 42859

  • Forschungszentrum Ruhr - KliFoCenter GmbH

    Witten, North Rhine-Westphalia, 58455

Other trials in Germany

Austria9 sites

  • Krankenhaus St. Josef Braunau

    Braunau am Inn, Upper Austria, 5280

  • Medizinische Universität Graz

    Graz, Styria, 8036

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, Carinthia, 9020

  • Kepler Universitätsklinikum Campus III

    Linz, Upper Austria, 4021

  • Universitätsklinikum St. Pölten

    Sankt Pölten, Lower Austria, 3100

  • Universitätsklinikum AKH Wien

    Vienna, 1090

  • Klinik Ottakring - Wilhelminenspital

    Vienna, 1160

  • Klinik Floridsdorf - Krankenhaus Nord

    Vienna, 1210

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt, Lower Austria, 2700

Other trials in Austria

Sweden9 sites

  • Falu Lasarett

    Falun, 791 82

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Länssjukhuset Ryhov

    Jönköping, 551 85

  • Skånes Universitetssjukhus

    Lund, 222 42

  • Universitetssjukhuset Örebro

    Örebro, 701 85

  • Danderyds sjukhus

    Stockholm, 182 88

  • Länssjukhuset Sundsvall-Härnösand

    Sundsvall, 851 86

  • Akademiska sjukhuset Hjärtforskningsmottagningen

    Uppsala, 751 85

  • Västmanlands Sjukhus Västerås

    Västerås, 721 89

Other trials in Sweden

Belgium8 sites

  • OL Vrouwziekenhuis - Campus Aalst

    Aalst, 9300

  • Imeldaziekenhuis - St-Elisabethkliniek

    Bonheiden, 2820

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

    Bruges, 8000

  • CU Saint-Luc/UZ St-Luc

    Bruxelles - Brussel, 1200

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • Jessa Ziekenhuis

    Hasselt, 3500

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHR de la Citadelle - Cardiology

    Liège, 4000

Other trials in Belgium

Poland8 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

  • Szpital sw. Wincentego a Paulo

    Gdynia, 81-348

  • Samodzielny Publiczny Specjalistyczny Szpital Zachodni

    Grodzisk Mazowiecki, 05-825

  • Uniwersytecki Szpital Kliniczny w Opolu

    Opole, 45-401

  • Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej

    Rzeszów, 35-301

  • Uniwersyteckie Centrum Kliniczne Warszawskiego UM

    Warsaw, 02-097

  • Szpital Grochowski im. dr.med. Rafala Masztaka

    Warsaw, 04-073

  • Uniwersytecki Szpital Kliniczny UM we Wroclawiu

    Wroclaw, 50-556

Other trials in Poland

Switzerland7 sites

  • Kantonsspital Aarau

    Aarau, Canton of Aargau, 5001

  • Kantonsspital Baden

    Baden, 5404

  • Hôpital Cantonal Universitaire de Genève

    Geneva, 1205

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, Canton of Vaud, 1011

  • Kantonsspital Baselland - Standort Liestal

    Liestal, Basel-Landschaft, 4410

  • Luzerner Kantonsspital

    Lucerne, 6000

  • Ospedale regionale di Lugano

    Lugano, 6900

Other trials in Switzerland

United Kingdom5 sites

  • Imperial College London

    London, W12 0HS

  • Wythenshawe Hospital

    Manchester, M23 9LT

  • Freeman Hospital

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN

  • Lister Hospital

    Stevenage, Hertfordshire, SG1 4AB

  • Worcestershire Acute Hospital Trust

    Worcester, Worcestershire, WR5 1DD

Other trials in United Kingdom

About this study

Official title: 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

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.

Being tested
BAY2433334, BAY2433334 matching placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY2433334Drug

    Tablet, taken orally once a day.

  • BAY2433334 matching placeboOther

    Tablet, taken orally once a day.

Study groups in NCT04304534
Study groupRoleWhat they receive
BAY 2433334 high doseExperimentalNot described
Receives: Drug: BAY2433334
BAY 2433334 medium doseExperimentalNot described
Receives: Drug: BAY2433334
BAY 2433334 low doseExperimentalNot described
Receives: Drug: BAY2433334
BAY2433334 matching placeboPlacebo comparatorNot described
Receives: Other: BAY2433334 matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From baseline up to 52 weeks

  2. 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.

    Measured: From baseline up to 52 weeks

Secondary outcomes (8)

  1. 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.

    Measured: From baseline up to 52 weeks

  2. 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.

    Measured: From baseline up to 52 weeks

  3. 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.

    Measured: From baseline up to 52 weeks

  4. 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

    Measured: From baseline up to 52 weeks

  5. Efficacy - Number of Participants With All Cause Mortality

    Measured: From baseline up to 52 weeks

  6. 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

    Measured: From baseline up to 52 weeks

  7. Safety - Number of Participants With BARC Bleeding Definition Type 3, 5

    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.

    Measured: From baseline up to 52 weeks

  8. 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. For BARC bleeding definition 2,3 and 5, please refer to second primary endpoint.

    Measured: From baseline up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2020
  2. Study start17 Jun 2020
  3. Primary completion21 Feb 2022
  4. Study completion21 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,601 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04304534
Sponsor's protocol ID
20603
Other IDs
2019-003244-79, 2019
Acronym
PACIFIC-AMI
Status last verified
Apr 2023
First submitted
8 Mar 2020
Last updated
5 Apr 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

  • 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.

    PubMed 38038437

  • 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.

    PubMed 36030390

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY2433334 in people with Acute Myocardial Infarction, run by Bayer at 160 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 160 sites in United States, Japan, Italy, Netherlands, Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy - Number of Participants With Composite of CV Death, MI, Stroke and Stent Thrombosis (ST) (time frame: From baseline up to 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04304534, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.

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