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

Bayer1,601 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,601

Conditions

Acute Myocardial Infarction

Interventions

BAY2433334

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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.

Locations (160)

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

Outcomes

Primary Outcomes

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