Acute Ischemic Stroke Trial-1 : Oral Aspirin vs Intravenous Heparin on Stroke Progression

초록

Background : Though recent large clinical trials has demonstrated modest effect of oral aspirin in acute ischemic stroke, over control or subcutaneous heparin, they did not include conventional intravenous heparin for the comparison. Old trials regarding intravenous heparin were also insufficient to suggest a conclusion except for cardioembolic stroke. Objectives : We thus designed this trial as we thought that the effect of intravenous heparin versus oral aspirin on acute ischemic stroke progression should be clarified first, before other agents is tested for similar purpose, as there is yet no consensus of standard treatment. Methods : This study is designed as multi-center, prospective, single-blinded, randomized controlled study. Acute ischemic stroke patients within 48 hours from the onset are eligible for the study. Cardioembolic stroke, TIA, large infarct requiring intracranial pressure control, severe stroke such as basilar occlusion, and stroke indicated to thrombolytic therapy has been excluded. Patients are then randomized through the Internet to either heparin or aspirin group as soon as they are enrolled. Aspirin group receive oral aspirin 300 mg daily, on arrival and during the study period. Heparin group is given intravenous heparin for initial 6 days with activated partial thromboplastin time monitoring, then switched to aspirin. National Institute of Health Stroke Scale (NIHSS) is checked daily for 1 week. Barthel Index (BI) and Modified Rankin Scale (MRS) is also checked at 3 month, with NIHSS. Primary outcome is progression in acute stage (defined as worsening of NIHSS more than 1 point within a week), while secondary outcome is BI and MRS at 3 month. Subgroup analysis will be also performed by our modified TOAST classification system, which separates branch atheromatous disease from large artery atherosclerosis or small artery occlusion. Interim result will be presented at the Congress.