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NCT00809965 · ClinicalTrials.gov registry record · Phase 3

An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

A Phase 3 study of Myocardial Infarction and Acute Coronary Syndrome, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed
Registry status
Phase 3
Development phase
15,526
Enrollment target
20
Study locations

NCT00809965: Completed Phase 3 study of Myocardial Infarction and Acute Coronary Syndrome, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

NCT00809965 is a Phase 3 study of Myocardial Infarction and Acute Coronary Syndrome that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 15,526 participants, above the 4,439-participant average among 64 other Myocardial Infarction trials with a reported enrollment target (250% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00809965, a Phase 3 study of Myocardial Infarction and Acute Coronary Syndrome, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

COMPLETED
Registry status
Phase 3
Development phase
15,526 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

Primary Outcome

The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.

Interventions

  • DRUG Placebo
  • DRUG Standard of care
  • DRUG Rivaroxaban 2.5 mg
  • DRUG Rivaroxaban 5 mg

Study Locations (20)

Florida

  • - Jacksonville
  • - Jupiter
  • - Kissimmee
  • - Miami
  • - Ocala
  • - Orlando
  • - Ormond Beach
  • - St. Petersburg

California

  • - Anaheim
  • - Burbank
  • - Los Angeles
  • - Mission Hills
  • - San Diego

Alabama

  • - Birmingham
  • - Geneva
  • - Mobile

Colorado

  • - Aurora
  • - Littleton

Georgia

  • - Columbus
  • - Rome

Trial Details

FieldValue
Enrollment Target 15,526 participants
Start Date 2008-11
Est. Completion 2011-09
Phase Phase 3

What the finished NCT00809965 record still lists

NCT00809965 is an interventional study that assigns participants to a tested intervention. Its 15,526 participants enrollment target places it among the larger protocols in the corpus, above the 4,439-participant average among 64 other Myocardial Infarction trials with a reported enrollment target (250% higher).

The record links to 4 conditions, with Myocardial Infarction appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT00809965 names 20 study sites across 5 states, led by Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT00809965 about?

NCT00809965 is a clinical study titled "An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome". The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

What is the current status of trial NCT00809965?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 15,526 participants. The study started on 2008-11. Estimated completion is 2011-09.

What conditions does trial NCT00809965 study?

This clinical trial studies the following conditions: Myocardial Infarction, Acute Coronary Syndrome, Myocardial Ischemia, Unstable Angina.

What interventions are being tested in trial NCT00809965?

The interventions under investigation include: Placebo (DRUG), Standard of care (DRUG), Rivaroxaban 2.5 mg (DRUG), Rivaroxaban 5 mg (DRUG).

Who is sponsoring clinical trial NCT00809965?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00809965 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Myocardial Infarction

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00809965's enrollment target sits among peer trials

15,526 2nd of 64 the highest of 64 other Myocardial Infarction trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Myocardial Infarction 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 NCT00809965, the US trial registry maintained by the National Library of Medicine. NCT00809965 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.