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Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE W)

NCT00243178 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6706

Last updated 2009-10-19

No results posted yet for this study

Summary

The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a vitamin K antagonist) will result in the same risk of the composite outcome of stroke, non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy.

Conditions

Interventions

DRUG

clopidogrel (SR25990C)

75 mg once daily in combination with aspirin

Sponsors & Collaborators

Principal Investigators

  • Salim YUSUF, Prof. · Hamilton Health Sciences Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2005-09-30
Completion
2005-09-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Singapore
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00243178 on ClinicalTrials.gov