ACTIVE W

The Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events W (2006)

Condition

Prevention of vascular events in patients with AF and increased risk for stroke

Close this section

Objective

To establish that clopidogrel plus ASA is non-inferior to standard oral anticoagulation therapy for prevention of vascular events in patients with AF

Close this section

Trial design

Randomized, open trial
Active treatment: clopidogrel 75 mg plus ASA 75–100 mg once daily (n=3335)
Control treatment: oral anticoagulation (INR 2.0–3.0) (n=3371)

Close this section

Endpoints

Primary endpoint: composite of stroke, non-CNS systemic embolus, myocardial infarction, and vascular death
Secondary endpoints: stroke, stroke severity, total mortality, major and minor hemorrhages, net benefit

Close this section

Trial participants

6706 patients (mean age 70 years) with a documented history of permanent, persistent, or at least 2 episodes of paroxysmal atrial fibrillation and at least one additional risk factor for stroke

Close this section

Results

Efficacy outcome: The study was stopped early because of clear evidence of superiority of oral anticoagulation. In the intent-to-treat population, 165 primary events occurred in the group with oral anticoagulation (annual risk 3.9%) compared to 234 in the clopidogrel/ASA group (annual risk 5.6%). The increase in relative risk for clopidogrel/ASS was 44%. Patients already receiving oral anticoagulation therapy at study entry had a greater reduction in vascular events than patients starting with oral anticoagulation treatment at study entry
Safety outcome: Rates of major hemorrhage were similar in the two groups (annual rate 2.4% with clopidogrel/ASA and 2.2% with oral anticoagulation). Significantly more minor bleeds occurred with clopidogrel/ASA than with oral anticoagulation. Patients already receiving oral anticoagulation therapy at study entry had a significantly lower risk of major bleeding than patients starting with oral anticoagulation treatment at study entry

Close this section

Summary

Efficacy outcome: Oral anticoagulation therapy was superior to clopidogrel/ASA for prevention of vascular events in AF patients with high risk for stroke, especially in patients already taking oral anticoagulation therapy at study entry
Safety outcome: Rates of major bleedings were comparable between groups. The net benefit (primary outcome event plus major hemorrhage) favored oral anticoagulation therapy (p<0.0001)

Close this section

Reference

Connolly S, Yusuf S, Camm J, Chrolavicius S, Commerford P, Flather M, Hart RG, Hohnloser S, Joyner C, Pfeffer M, Pogue J, for the ACTIVE Investigators. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet 2006;367:1903-1912

Close this section

Corresponding author

Stuart J Connolly, MD, Hamilton Health Sciences Corporation, Hamilton General Site, 237 Barton Street East, Hamilton, ON L8L 2X2, Canada,
e-mail:connostu@phri.ca

Close this section

Back To List

Recommend pageBack to top