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Recurrent Ischemic Lesions After Acute Atherothrombotic Stroke: Clopidogrel Plus Aspirin Versus Aspirin Alone
Keun-Sik Hong1, Seung-Hoon Lee1, Eung Gyu Kim1
1From the Department of Neurology, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea (K.-S.H., Y.-J.C.); Department of Neurology (S.-H.L., B.-W.Y.) and Department of Diagnostic Radiology (C.-H.S.), Seoul National University Hospital, Republic of Korea; Department of Neurology, Inje University Busan Paik Hospital, Republic of Korea (E.G.K.); Department of Neurology, Chonnam National University Hospital, Gwangju, Republic of Korea (K.-H.C.); Department of Neurology, Kyung Hee University Medical Center, Seoul, Republic of Korea (D.I.C.); Department of Neurology, Inha University Hospital, Incheon, Republic of Korea (J.-H.R.); Department of Neurology, Seoul National University Bundang Hospital, Gyeonggi-do, Republic of Korea (H.-J.B.); Department of Neurology, Soonchunhyang University Hospital, Seoul, Republic of Korea (K.B.L.); Department of Neurology, Dongguk University Medical Center, Goyang, Republic of Korea (D.E.K.); Department of Neurology, Eulji General Hospital, Seoul, Republic of Korea (J.-M.P.); Department of Neurology, Konkuk University Medical Center, Seoul, Republic of Korea (H.-Y.K.); Department of Neurology, Dong-A University Hospital, Busan, Republic of Korea (J.-K.C.); Department of Neurology, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea (K.-H.Y.); Department of Neurology, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea (Y.-S.L.); Department of Neurology, Eulji University Hospital, Daejeon, Republic of Korea (S.J.L.); Department of Neurology, Jeju National University Hospital, Republic of Korea (J.C.C.); Department of Neurology, Asan Medical Center, Seoul, Republic of Korea (S.U.K., D.-W.K.); Department of Neurology, Samsung Medical Center, Seoul, Republic of Korea (G.-M.K.); Department of Neurology, Dongsan Medical Center, Keimyung University, Daegu, Republic of Korea (S.-I.S.); Department of Neurology, Chung-Ang University Hospital, Seoul, Republic of Korea (K.-Y.P.); and Department of Neurology, Yeungnam Uni
Background And Purpose:
In patients with acute ischemic stroke caused by large artery atherosclerosis, clopidogrel plus aspirin versus aspirin alone might be more effective to prevent recurrent cerebral ischemia. However, there is no clear evidence.
Methods:
In this multicenter, double-blind, placebo-controlled trial, we randomized 358 patients with acute ischemic stroke of presumed large artery atherosclerosis origin within 48 hours of onset to clopidogrel (75 mg/d without loading dose) plus aspirin (300-mg loading followed by 100 mg/d) or to aspirin alone (300-mg loading followed by 100 mg/d) for 30 days. The primary outcome was new symptomatic or asymptomatic ischemic lesion on magnetic resonance imaging within 30 days. Secondary outcomes were 30-day functional disability, clinical stroke recurrence, and composite of major vascular events. Safety outcome was any bleeding.
Results:
Of 358 patients enrolled, 334 (167 in each group) completed follow-up magnetic resonance imaging. The 30-day new ischemic lesion recurrence rate was comparable between the clopidogrel plus aspirin and the aspirin monotherapy groups (36.5% versus 35.9%; relative risk, 1.02; 95% confidence interval, 0.77-1.35; P=0.91). Of the recurrent ischemic lesions, 94.2% were clinically asymptomatic. There were no differences in secondary outcomes between the 2 groups. Any bleeding were more frequent in the combination group than in the aspirin monotherapy group, but the difference was not significant (16.7% versus 10.7%; P=0.11). One hemorrhagic stroke occurred in the clopidogrel plus aspirin group.
Conclusions:
Clopidogrel plus aspirin might not be superior to aspirin alone for preventing new ischemic lesion and clinical vascular events in patients with acute ischemic stroke caused by large artery atherosclerosis.
Clinical Trial Registration:
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00814268.
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