6/28/23, 12:01 AM ACTIVE W Pathway Feedback Search Clinical Topics Home Studies ACTIVE W ACTIVE W Disease Disease Disease Acute ischemic stroke Atrial fibrillation Transient 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 N = 6706 66.0% male 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 mitral stenosis Interventions N=3371 oral anticoagulation therapy (a vitamin K antagonist, 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 https://web.pathway.md/studies/rechCLTv55RiTcLLM 1/2 6/28/23, 12:01 AM ACTIVE W Pathway Incidence of stroke, non-CNS systemic embolus, myocardial infarction, or vascular death 5.6 % / y 5.6 4.2 % / y 3.93 2.8 % / y 1.4 % / y Significant increase 0.0 % / y Oral anticoagulation therapy Dual antiplatelet therapy 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. Open reference URL https://web.pathway.md/studies/rechCLTv55RiTcLLM 2/2