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.
Author(s): Wang Y, Johnston SC; CHANCE Investigators.
Collaborators: Wang Y, Johnston SC, Nguyen-Huynh MN, Cui L, Jia J, Wu J, Dong Q,
Zeng J, Zhao Z, Zhao X, Wang C, Li H, Wang Y, Zhou Y, Li Y, Xu A, Gao P, Gao P,
Wong KS, Zhang S, Zhang W, Wang Z.
Affiliation(s): Beijing Tian Tan Hospital, Capital Medical University, China. yilong528@gmail.com
Publication date & source: 2010, Am Heart J. , 160(3):380-386
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.
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