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 infarctio

Phase 2

Completed

• Conditions: Acute Coronary Syndrom; Myocardial Infarction; 10028593

• Registration Number: NL-OMON54974
• Lead Sponsor: Bayer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 196

Inclusion Criteria

1. Participants must be 45 years of age or older, at the time of signing the
informed consent
2. Acute myocardial infarction (excluding MI associated with PCI or CABG
revascularization procedures) with:
a.clinical symptoms of acute myocardial infarction AND
b.elevated biomarkers of myocardial necrosis (creatine kinase-muscle and brain
isoenzyme [CK-MB] or cardiac troponins) AND
c.at least one of the following risk factors need to be fulfilled:
i. Age * 65 years
ii.Prior MI (before the index AMI event)
iii.Prior peripheral arterial disease
iv.Diabetes Mellitus
v.Prior coronary artery bypass grafting (CABG)
AND
d. 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)
3. Plan for dual antiplatelet therapy (ASA + P2Y12 inhibitor) after hospital
discharge for the index AMI
4. Randomization during hospitalization for the index AMI event and latest
within 5 days of hospital admission
5. 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

1. Hemodynamically significant ventricular arrhythmias or cardiogenic shock at
time of randomization
2. Active bleeding; known bleeding disorder, history of major bleeding
(intracranial, retroperitoneal, intraocular) or clinically significant
gastrointestinal bleeding within last 6 months of randomization
3. Planned use or requirement of full dose and long term anticoagulation
therapy during study conduct

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Efficacy Endpoint: the composite of CV death, MI, stroke and stent<br /><br>thrombosis<br /><br>Primary Safety Endpoint: Bleeding Academic Research Consortium (BARC)<br /><br>definition type 2, 3 and 5</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Efficacy Endpoints:<br /><br>- all cause mortality<br /><br>- CV death<br /><br>- MI<br /><br>- stroke<br /><br>- stent thrombosis<br /><br><br /><br>Secondary Safety Endpoints:<br /><br>- all bleeding<br /><br>- BARC bleeding definition type 3, 5<br /><br>- BARC bleeding definition type 1, 2, 3, 5</p><br>