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NCT00496769 · ClinicalTrials.gov registry record · Phase 3

A Phase III Study of Apixaban in Patients With Atrial Fibrillation

A Phase 3 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 3
Development phase
6,421
Enrollment target

NCT00496769: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.

NCT00496769 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 6,421 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (732% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00496769, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 3
Development phase
6,421 participants
Enrollment target

Study Summary

The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.

Primary Outcome

Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)

Interventions

  • DRUG Apixaban
  • DRUG Acetylsalicylic acid

Trial Details

FieldValue
Enrollment Target 6,421 participants
Start Date 2007-08-31
Est. Completion 2017-05-25
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

What the finished NCT00496769 record still lists

NCT00496769 is an interventional study that assigns participants to a tested intervention. Its 6,421 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (732% higher).

The record links to 0 conditions, and to 2 interventions - of which Apixaban is the first listed.

NCT00496769 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00496769 about?

NCT00496769 is a clinical study titled "A Phase III Study of Apixaban in Patients With Atrial Fibrillation". The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.

What is the current status of trial NCT00496769?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 6,421 participants. The study started on 2007-08-31. Estimated completion is 2017-05-25.

What interventions are being tested in trial NCT00496769?

The interventions under investigation include: Apixaban (DRUG), Acetylsalicylic acid (DRUG).

Who is sponsoring clinical trial NCT00496769?

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

How this trial's enrollment target compares

Where NCT00496769's enrollment target sits among peer trials

6,421 35th of 2000 higher than 1,966 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00496769, the US trial registry maintained by the National Library of Medicine. NCT00496769 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.