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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 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.

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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.

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

FieldValue
Enrollment Target 1,601 participants
Start Date 2020-06-17
Est. Completion 2022-02-21
Phase Phase 2

Sponsor

Bayer

591 total trials

What the Registry Record Tells You About NCT04304534

The ClinicalTrials.gov registry entry for NCT04304534 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,601 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,798-participant average among 19 other Acute Myocardial Infarction trials with a reported enrollment target (11% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.