The objective of ESPRIT is 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.

Condition	Intervention	Phase
Brain Ischemia TIA (Transient Ischemic Attack) Prevention & Control Arteriosclerosis	Drug: anticoagulation, aspirin and dipyridamole or aspirin alone	Phase IV

Further Study Details: 

Primary Outcomes: 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 Outcomes: 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 lower extremities; retinal infarction or bleeding
Expected Total Enrollment:  4500

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 is an open randomised controlled trial allocating patients who experienced a 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 will be three years. Primary outcome is the composite of vascular death, stroke, myocardial infarction or major bleeding. Outcome assessment is blind.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

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 3 or less

Exclusion Criteria:

• (contra)indication for 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, 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00161070

Ale Algra, Professor      00 31 30 250 9350    aalgra@umcutrecht.nl
Patricia HA Halkes, M.D.      00 31 30 250 8350    phalkes@umcutrecht.nl

Netherlands
      UMC Utrecht, Utrecht,  Netherlands; Recruiting

Study chairs or principal investigators

A. Algra, Professor,  Principal Investigator,  UMC Utrecht   
J. Gijn van, Professor,  Principal Investigator,  UMC Utrecht   

Study ID Numbers:  96-217; Heart Found.: 97.026; Eur. Com.: QLK6-CT-2002-02332
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00161070
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-09-13