ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

UMC Utrecht

Status and phase

Completed

Phase 4

Conditions

Brain Ischemia

Transient Ischemic Attack

Arteriosclerosis

Treatments

Drug: aspirin and dipyridamole

Drug: anticoagulation

Drug: aspirin alone

Study type

Interventional

Funder types

Other

Identifiers

NCT00161070

Heart Found.: 97.026

Eur. Com.: QLK6-CT-2002-02332

96-217

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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