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

Status and phase: Completed; Phase 2

Conditions: Acute Myocardial Infarction

Treatments: Other: BAY2433334 matching placebo; Drug: BAY2433334

Study type: Interventional

Funder types: Industry

Identifiers

NCT04304534

2019-003244-79 (EudraCT Number)

20603

Details and patient eligibility

About

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.

Enrollment: 1,601 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,601 participants in 4 patient groups, including a placebo group

BAY 2433334 high dose

Experimental group

Treatment:

Drug: BAY2433334

BAY 2433334 medium dose

Experimental group

Treatment:

Drug: BAY2433334

BAY 2433334 low dose

Experimental group

Treatment:

Drug: BAY2433334

BAY2433334 matching placebo

Placebo Comparator group

Treatment:

Other: BAY2433334 matching placebo