ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

4500 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-07-31

Study Completion Date

2006-12-31

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.

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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.

Conditions

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Brain Ischemia Transient Ischemic Attack Arteriosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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anticoagulation

Intervention Type DRUG

aspirin and dipyridamole

Intervention Type DRUG

aspirin alone

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No