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Citation: JNS Volume 187, Supplement 1, page S258, June 2001
S.-R. Han1, J.-H. Rha2, N.-C. Choi3, J.-Y. Kim4, H.-J. Song5, J. Kim6
1Kang-Nam St. Mary Hospital; 2Inha University; 3Gyong-Sang National University; 4Kyung-Book National University; 5Eulji University; 6Choong-Nam National University, Republic of Korea
Background: Though recent clinical trials have demonstrated modest effect of aspirin in acute ischemic stroke, over control or subcutaneous heparin, they didn't include conventional intravenous heparin for the comparison. Old trials regarding intravenous heparin were also insufficient to suggest a conclusion except for cardioembolic stroke.
Objective: To compare the effectiveness of intravenous heparin versus oral aspirin for the progression in acute ischemic stroke.
Methods: This study was designed as prospective, multi-center, single-blinded, randomized controlled trial. Ischemic stroke within 48 hours from the onset were eligible. Cardioembolic stroke, TIA, large infarct requiring ICP control, severe stroke such as basilar occlusion, and stroke indicated to thrombolytic therapy had been excluded. Patients were randomized to either heparin or aspirin group. Aspirin group received oral aspirin 300mg daily. Heparin group was given intravenous heparin for initial 6 days and switched to aspirin. NIH Stroke Scale(NIHSS) was checked daily for 1 week. Barthel Index(BI) and Modified Rankin Scale(MRS) were checked at 3 months, with NIHSS. Primary outcome was progression in acute stage (worsening of NIHSS more than 1 point within a week), while secondary outcome was BI and MRS at 3 months. Subgroup analysis was performed by our modified TOAST classification. Results: From Sept. 1999 to June 2000, 113 patients were enrolled (male 65, female 48; age 39 77, mean 62). 21 patients(18.5%) were dropped out. 6 patients(12.8%) in aspirin group(n=47) progressed during first week, while 13.3%(6 patients) did in heparin group(n=45). The difference didn't reach statistical significance.
Conclusion: The randomization will end on Aug. 2001. The final result will elucidate the proper treatment of acute ischemic stroke. If there is no difference between the two therapeutic options, aspirin will be preferred choice for the prevention of acute stroke progression, considering fewer side effects.
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