6/28/23, 12:01 AM ACTIVE A Pathway Feedback Search Clinical Topics Home Studies ACTIVE A ACTIVE A Disease Disease Disease Acute ischemic stroke Atrial fibrillation Transient Trial question What is the effect of clopidogrel addition to aspirin in patients with AF for whom vitamin K-antagonist therapy was unsuitable? Study design Multi-center Double blinded RCT Population Characteristics of study participants 42.0% female N = 7554 58.0% male 7554 patients (3157 female, 4397 male) Inclusion criteria: patients with AF who had an increased risk of stroke and for whom vitamin K- antagonist therapy was unsuitable Key exclusion criteria: requirement of a vitamin K antagonist or clopidogrel, documented peptic ulcer disease within the previous 6 months, history of intracerebral hemorrhage, significant thrombocytopenia (platelet count < 50 10 /L), or ongoing alcohol abuse Interventions N=3772 clopidogrel (at a dose of 75 mg once daily plus aspirin 75-100 mg/day) N=3782 placebo (matching placebo once daily plus aspirin 75-100 mg/day) https://web.pathway.md/studies/recl6zB15oQfjDd7D 1/2 6/28/23, 12:01 AM ACTIVE A Pathway Primary outcome Incidence of stroke, myocardial infarction, non-central nervous system systemic embolism, or death from vascular causes, at a median of 3.6 years of follow-up 7.6 % / y 7.6 6.8 5.7 % / y 3.8 % / y 1.9 % / y Significant decrease 0.0 % / y Clopidogrel Placebo Significant decrease in the incidence of stroke, myocardial infarction, non-CNS systemic embolism, or death from vascular causes, at a median of 3.6 years of follow-up (6.8% / y vs. 7.6% / y; RR 0.89, 95% CI 0.81 to 0.98) Secondary outcomes Significant decrease in the incidence of stroke (2.4% / y vs. 3.3% / y; RR 0.72, 95% CI 0.62 to 0.83) No significant difference in the incidence of myocardial infarction (0.7% / y vs. 0.9% / y; RR 0.78, 95% CI 0.59 to 1.03) Safety outcomes Significant differences in major bleeding (2.0% vs. 1.3%, p < 0.001; RR 1.57, 95% CI 1.29-1.92). Conclusion In patients with AF who had an increased risk of stroke and for whom vitamin K-antagonist therapy was unsuitable, clopidogrel was superior to placebo with respect to the incidence of stroke, myocardial infarction, non-CNS systemic embolism, or death from vascular causes, at a median of 3.6 years of follow-up. Reference ACTIVE Investigators, Connolly SJ, Pogue J et al. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med. 2009 May 14;360(20):2066-78. Open reference URL https://web.pathway.md/studies/recl6zB15oQfjDd7D 2/2