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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT04304534

Run by

Bayer

People needed

1601

Starts

2020-06-17

Expected to finish

2022-02-21

Last updated by the study team

2023-04-05

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Valley Clinical Trials, Inc. - Covina — Covina, California, United States

Full record on ClinicalTrials.gov

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