ACTIVE A Trial

Overview
ACTIVE A is a randomized controlled trial of Clopidogrel vs ASA vs Placebo + ASA in the management of atrial fibrillation. 11% were previously on oral anticoagulants, but to enter the trial the patient could not remains on an anticoagulant during the trial.

Inclusion criteria
Documented atrial fibrillation Risk factor for stroke (similar to CHADS score)

Exclusion
Requirement for clopidogrel Risk factors for bleeding

Design
Randomized controlled trial. Clopidogrel vs ASA vs Placebo + ASA

Sample size
N=7,554

Efficacy Endpoint
Endpoints are being adjudicated

Safety Endpoint
Major hemorrhage: 2 unit transfusion, death, 5 g/dl drop in Hb.

Planned date of presentation
ACC 2009

Physicians could elect to enroll patients in this trial, or in ACTIVE W.