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

Abstract

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.