ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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). The mean follow-up was three years. Primary outcome was the composite of vascular death, stroke, myocardial infarction or major bleeding. Outcome assessment is blind.

Official Title
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ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

Conditions
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Brain Ischemia, Transient Ischemic Attack, Arteriosclerosis

Intervention / Treatment
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* Drug: anticoagulation
* Drug: aspirin and dipyridamole
* Drug: aspirin alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: (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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: anticoagulation|nan|
|Drug: aspirin and dipyridamole|nan|
|Drug: aspirin alone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The combined event of death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction or major bleeding complication, whichever happens first during follow-up |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from all causes |  |  | 
| death from vascular causes |  |  | 
| death from vascular causes or nonfatal stroke |  |  | 
| fatal or nonfatal stroke |  |  | 
| death from vascular causes, nonfatal stroke, nonfatal myocardial infarction or vascular intervention |  |  | 
| major bleeding complications |  |  | 
| amputations of lower extremities |  |  | 
| retinal infarction or bleeding |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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secondary prevention, TIA / minor stroke, atherosclerotic origin, TIA (Transient Ischemic Attack), prevention & control