ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 4,500
- 试验地点
- 1
- 主要终点
- The combined event of death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction or major bleeding complication, whichever happens first during follow-up
研究概览
简要总结
The objective of ESPRIT was to compare the efficacy and safety of mild anticoagulation or a combination treatment of aspirin and dipyridamole with the efficacy and safety of treatment with aspirin alone after cerebral ischemia of arterial origin.
详细描述
Low-dose aspirin (ASA) (at least 30 mg/day) prevents only 13% of subsequent vascular events after minor cerebral ischemia of arterial origin. Anticoagulation (AC) has been proven highly effective in preventing vascular events after myocardial infarction and after cerebral ischemia in patients with atrial fibrillation. A previous study on the effects of AC after cerebral ischemia of arterial origin (SPIRIT) showed that high intensity AC (INR 3.0 to 4.5) is not safe, but that mild AC (INR 2.0 to 3.0) was. The 2nd European Stroke Prevention Trial (ESPS-2) reported a 22% relative risk reduction of the combination of ASA and dipyridamole (DIP) above that of ASA only; its results, however, are subject to debate.
Study design: ESPRIT was an open randomised controlled trial allocating patients who experienced a transient ischemic attack (TIA) or a non-disabling ischemic stroke to either:
A. oral AC (INR 2.0 to 3.0);
B. the combination of DIP (400 mg daily) plus ASA (30-325 mg/day); or
C. ASA only (same dose).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting in the participating hospitals with a TIA or non-disabling stroke of atherosclerotic origin
- •Randomisation within 6 months after the TIA or minor stroke
- •Modified Rankin scale of 3 or less
排除标准
- •(Contra)indication to, or intolerance to, anticoagulants, dipyridamole, or aspirin
- •Disease expected to cause death within weeks or months
- •Source of embolism in the heart
- •Moderate or severe ischemic damage to the white matter of the brain (leukoaraiosis)
- •Anemia, polycythemia, thrombocytosis, or thrombocytopenia
- •Planned carotid endarterectomy
- •Intracranial bleeding or cerebral tumour
- •TIA or stroke caused by vasculitis, migraine, or dissection
- •Severe hypertension
- •Liver failure
- •Pregnancy
- •Chronic alcohol abuse
结局指标
主要结局
The combined event of death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction or major bleeding complication, whichever happens first during follow-up
次要结局
- major bleeding complications
- Death from all causes
- death from vascular causes
- death from vascular causes or nonfatal stroke
- fatal or nonfatal stroke
- retinal infarction or bleeding
- death from vascular causes, nonfatal stroke, nonfatal myocardial infarction or vascular intervention
- amputations of lower extremities