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NCT04304534 · ClinicalTrials.gov registry record · Phase 2
Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack
A Phase 2 study of Acute Myocardial Infarction, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,601
- Enrollment target
- 20
- Study locations
NCT04304534: Completed Phase 2 study of Acute Myocardial Infarction, sponsored by Bayer.
NCT04304534 is a Phase 2 study of Acute Myocardial Infarction that has completed, run by Bayer. The registered enrollment target is 1,601 participants, below the 1,798-participant average among 19 other Acute Myocardial Infarction trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04304534, a Phase 2 study of Acute Myocardial Infarction, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,601 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG BAY2433334
- OTHER BAY2433334 matching placebo
Study Locations (20)
Florida
- Florida Premier Cardiology - Boynton Beach
- Clearwater Cardiovascular Associates | Clearwater, FL - Clearwater
- Cardiology Associates Research Company - Daytona Beach
- Southwest Florida Research - Naples
- Cardiology Partners Clinical Research Institute - Palm Beach Gardens
Louisiana
- Cardiovascular Associates Research, LLC - Covington
- Southern Clinical Research, LLC - Zachary
Maryland
- Maryland Cardiovascular Specialists - Baltimore
- White Oak Medical Center - Silver Spring
California
- Valley Clinical Trials, Inc. - Covina - Covina
Georgia
- Columbus Regional Research Institute - Columbus
Indiana
- Reid Health - Richmond
Kansas
- Midwest Heart & Vascular Specialists - Overland Park
Minnesota
- St. Mary's/Duluth Clinic Health System - Duluth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,601 participants |
| Start Date | 2020-06-17 |
| Est. Completion | 2022-02-21 |
| Phase | Phase 2 |
What the finished NCT04304534 record still lists
NCT04304534 is an interventional study that assigns participants to a tested intervention. Its 1,601 participants enrollment target places it among the larger protocols in the corpus, below the 1,798-participant average among 19 other Acute Myocardial Infarction trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Acute Myocardial Infarction appearing as the primary indexed condition, and to 2 interventions - of which BAY2433334 is the first listed.
NCT04304534 names 20 study sites across 14 states, led by Florida, Louisiana, Maryland.
Frequently Asked Questions
What is clinical trial NCT04304534 about?
NCT04304534 is a clinical study titled "Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack". 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) tha...
What is the current status of trial NCT04304534?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,601 participants. The study started on 2020-06-17. Estimated completion is 2022-02-21.
What conditions does trial NCT04304534 study?
This clinical trial studies the following conditions: Acute Myocardial Infarction.
What interventions are being tested in trial NCT04304534?
The interventions under investigation include: BAY2433334 (DRUG), BAY2433334 matching placebo (OTHER).
Who is sponsoring clinical trial NCT04304534?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04304534 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myocardial Infarction
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04304534's enrollment target sits among peer trials
1,601 6th of 19 higher than 14 of 19 other Acute Myocardial Infarction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myocardial Infarction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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