摘要
Acute stroke is a substantial public health problem.So far,numerous treatments have been suggested for acute ischaemic stroke,but non has been shown to be effective either because few theoretical benefits have been born out in practice,or much more often because the clinical trials have been too small to show any treatment effect.The Chinese Large Scale Stroke Clinical Trial is a randomizedly controlled and multicentre study of the value of antiplatelet therapy in the acute phase of ischaemic stroke(within 48 hours after onset of symptoms of stroke).Its chief aim is to obtain a reliable assessment of the separate effects on mortality and on disability in survivals of antithrombotic regiments.The study is intended to recruit 20000 patients.Diagnosis of stroke is a clinical one,and exclusion of patients with TIA and intracranial hemorrhage by CT scanning before randomization should be made in comatose patients.Patients will be randomized by sealed envelops which contain random numbers,and the allocated treatment is oral aspirin 160 mg daily or placebo to be continued for four weeks or until discharge (or transfer).The trial procedures are very simple and only two forms have to be completed in four weeks after randomization.No special follow ups for the trial or special monitoring is required.The pilot study has been conducted at ten hospitals in this country since April,1993.
Acute stroke is a substantial public health problem.So far,numerous treatments have been suggested for acute ischaemic stroke,but non has been shown to be effective either because few theoretical benefits have been born out in practice,or much more often because the clinical trials have been too small to show any treatment effect.The Chinese Large Scale Stroke Clinical Trial is a randomizedly controlled and multicentre study of the value of antiplatelet therapy in the acute phase of ischaemic stroke(within 48 hours after onset of symptoms of stroke).Its chief aim is to obtain a reliable assessment of the separate effects on mortality and on disability in survivals of antithrombotic regiments.The study is intended to recruit 20000 patients.Diagnosis of stroke is a clinical one,and exclusion of patients with TIA and intracranial hemorrhage by CT scanning before randomization should be made in comatose patients.Patients will be randomized by sealed envelops which contain random numbers,and the allocated treatment is oral aspirin 160 mg daily or placebo to be continued for four weeks or until discharge (or transfer).The trial procedures are very simple and only two forms have to be completed in four weeks after randomization.No special follow ups for the trial or special monitoring is required.The pilot study has been conducted at ten hospitals in this country since April,1993.
关键词
脑缺血
中风
抗凝疗法
stroke
antiplatelet therapy
multicentre study
design
