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

  • STATUS
    Recruiting
  • End date
    Feb 12, 2022
  • participants needed
    1600
  • sponsor
    Bayer
Updated on 3 April 2021
angiography
aspirin
clot
troponin
clopidogrel
antiplatelet therapy
ck-mb

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 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.

Details
Condition Acute Myocardial Infarction
Treatment BAY2433334, BAY2433334 matching placebo
Clinical Study IdentifierNCT04304534
SponsorBayer
Last Modified on3 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 45 yrs?
Gender: Male or Female
Do you have Acute Myocardial Infarction?
Do you have any of these conditions: Do you have Acute Myocardial Infarction??
Do you have any of these conditions: Do you have Acute Myocardial Infarction??
Do you have any of these conditions: Do you have Acute Myocardial Infarction??
Do you have any of these conditions: Do you have Acute Myocardial Infarction??
Do you have any of these conditions: Do you have Acute Myocardial Infarction??
Do you have any of these conditions: Do you have Acute Myocardial Infarction??
Do you have any of these conditions: Do you have Acute Myocardial Infarction??
Do you have any of these conditions: Do you have Acute Myocardial Infarction??
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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