Rationale and design of a randomized, double-blind trial comparing the effects of a 3-month clopidogrel-aspirin regimen versus aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event

Background Acute nondisabling cerebrovascular events are common and often portend a disabling stroke. Aspirin is the only antiplatelet agent to have been studied in patients presenting acutely with a cerebrovascular event, but the effect is modest and is reduced by a small increased risk of intracerebral hemorrhage. Treatment with the combination of clopidogrel and aspirin might be beneficial when taken soon after a transient ischemic attack (TIA) or minor stroke. The CHANCE trial is a randomized, double-blind, multicenter, placebo-controlled trial to test an aggressive antiplatelet regimen in acute minor stroke or TIA. Design The study will randomize 5,100 Chinese patients with acute TIA or minor stroke to receive a 3-month regimen of clopidogrel initiated with a loading dose of 300 mg followed by 75 mg/d, combined with aspirin 75 mg/d during the first 21 days, or a 3-month regimen of aspirin 75 mg/d alone. The primary efficacy end point is percentage of patients with any stroke (ischemic or hemorrhage) at 3 months. Study visits will be performed on the day of randomization, at day 21, and at day 90. Summary CHANCE will determine whether clopidogrel combined with aspirin can prevent more strokes after acute minor stroke or TIA compared with aspirin alone-with an acceptable risk profile. (Am Heart J 2010; 160:380-386.e1.)