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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 4,614 participants |
| Start Date | 2015-06-04 |
| Est. Completion | 2018-11-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗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.
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