Phase 2
Completed N=1,601
Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack
Source: ClinicalTrials.gov NCT04304534 ↗Enrolled (actual)
1,601
Serious AEs
19.2%
Results posted
Apr 2023
Primary outcomePrimary: Efficacy - Number of Participants With Composite of CV Death, MI, Stroke and Stent Thrombosis (ST) — 27; 24; 22; 22 Participants — p== 0.8439
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy - Number of Participants With Composite of CV Death, MI, Stroke and Stent Thrombosis (ST) |
27; 24; 22; 22 | = 0.8439 |
| PRIMARY Safety - Number of Participants With BARC Bleeding Definition Type 2, 3 and 5 |
30; 32; 42; 36; 104 | = 0.9158 |
| SECONDARY Efficacy - Number of Participants With CV Death |
7; 4; 5; 2 | — |
| SECONDARY Efficacy - Number of Participants With MI |
18; 20; 18; 17 | — |
| SECONDARY Efficacy - Number of Participants With Stroke |
4; 3; 0; 2 | — |
| SECONDARY Efficacy - Number of Participants With Stent Thrombosis |
4; 5; 4; 4 | — |
| SECONDARY Efficacy - Number of Participants With All Cause Mortality |
10; 7; 10; 7 | = 0.6016 |
| SECONDARY Safety - Number of Participants With All Bleeding |
70; 75; 82; 85 | — |
| SECONDARY Safety - Number of Participants With BARC Bleeding Definition Type 3, 5 |
5; 3; 3; 5 | — |
| SECONDARY Safety - Number of Participants With BARC Bleeding Definition Type 1,2,3,5 |
70; 75; 82; 85 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04304534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.