ACTIVE W
Trial question
Is oral anticoagulation therapy superior to clopidogrel plus aspirin in patients with AF at high risk for stroke?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
34.0% female
66.0% male
N = 6706
6706 patients (2276 female, 4430 male)
Inclusion criteria: patients with AF at high risk for stroke
Key exclusion criteria: contraindication for clopidogrel or OAC, documented peptic ulcer disease within the previous 6 months, previous intracerebral hemorrhage, significant thrombocytopenia, or MS
Interventions
N=3371 oral anticoagulation therapy (a VKA, to target INR between 2.0 and 3.3)
N=3335 dual antiplatelet therapy (clopidogrel 75 mg/day plus aspirin 75-100 mg/day)
Primary outcome
Incidence of stroke, non-CNS systemic embolus, myocardial infarction, or vascular death
3.93
5.6
5.6 % / y
4.2 % / y
2.8 % / y
1.4 % / y
0.0 % / y
Oral anticoagulation therapy
Dual antiplatelet therapy
Significant increase ▲
Significant increase in the incidence of stroke, non-CNS systemic embolus, myocardial infarction, or vascular death (3.93% / y vs. 5.6% / y; RR 1.44, 95% CI 1.18 to 1.76)
Secondary outcomes
Significant increase in the incidence of stroke (1.4% / y vs. 2.39% / y; RR 1.72, 95% CI 1.24 to 2.37)
Significant increase in vascular events in patients already on oral anticoagulation therapy at entry (3.72% vs. 5.5%; RR 1.5, 95% CI 1.19 to 1.89)
No significant difference in vascular events in patients not on oral anticoagulation therapy at entry (4.71% vs. 5.89%; RR 1.27, 95% CI 0.85 to 1.89)
Safety outcomes
Significant differences in major bleeding in patients already on anticoagulation therapy at entry (2.02% vs. 2.63% per year, p for interaction=0.03) and major bleeding for people not on oral anticoagulation at entry (2.92% vs. 1.73% per year, p = 0.09).
Conclusion
In patients with AF at high risk for stroke, oral anticoagulation therapy was superior to dual antiplatelet therapy with respect to the incidence of stroke, non-CNS systemic embolus, myocardial infarction, or vascular death.
Reference
ACTIVE Writing Group of the ACTIVE Investigators, Connolly S, Pogue J et al. 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 Jun 10;367(9526):1903-12.
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