Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02415400 · ClinicalTrials.gov registry record · Phase 4

A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart

A Phase 4 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 4
Development phase
4,614
Enrollment target

NCT02415400 is a Phase 4 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 4,614 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02415400, a Phase 4 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 4
Development phase
4,614 participants
Enrollment target

Study Summary

The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.

Interventions

  • DRUG Apixaban
  • DRUG Acetylsalicylic acid
  • DRUG vitamin K antagonist
  • OTHER Acetylsalicylic acid placebo

Trial Details

FieldValue
Enrollment Target 4,614 participants
Start Date 2015-06-04
Est. Completion 2018-11-10
Phase Phase 4

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT02415400

The ClinicalTrials.gov registry entry for NCT02415400 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 4,614 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Apixaban is the first listed.

NCT02415400 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02415400 about?

NCT02415400 is a clinical study titled "A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart". The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would...

What is the current status of trial NCT02415400?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 4,614 participants. The study started on 2015-06-04. Estimated completion is 2018-11-10.

What interventions are being tested in trial NCT02415400?

The interventions under investigation include: Apixaban (DRUG), Acetylsalicylic acid (DRUG), vitamin K antagonist (DRUG), Acetylsalicylic acid placebo (OTHER).

Who is sponsoring clinical trial NCT02415400?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

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

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.