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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: Completed Phase 4 study, sponsored by Bristol-Myers Squibb.
NCT02415400 is a Phase 4 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 4,614 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (791% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event
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 |
What the finished NCT02415400 record still lists
NCT02415400 is an interventional study that assigns participants to a tested intervention. Its 4,614 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (791% higher).
The record links to 0 conditions, and to 4 interventions - of which Apixaban is the first listed.
NCT02415400 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02415400's enrollment target sits among peer trials
4,614 18th of 2000 higher than 1,983 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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