ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

Transient Ischemic Attack Clinical Trial

Official title:

ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161070
• Other study ID #: 96-217
• Secondary ID: Heart Found.: 97
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: March 21, 2007
• Start date: July 1997
• Est. completion date: December 2006

Study information

• Verified date: March 2007
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4500
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriosclerosis
• Brain Ischemia
• Ischemia
• Ischemic Attack, Transient
• Transient Ischemic Attack

Intervention

Drug:
• anticoagulation

• aspirin and dipyridamole

• aspirin alone

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

ESPRIT Study Group, Halkes PH, van Gijn J, Kappelle LJ, Koudstaal PJ, Algra A. Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomised controlled trial. Lancet. 2006 May 20;367(9523):1665-73. Erratum — View Citation

ESPRIT Study Group, Halkes PH, van Gijn J, Kappelle LJ, Koudstaal PJ, Algra A. Medium intensity oral anticoagulants versus aspirin after cerebral ischaemia of arterial origin (ESPRIT): a randomised controlled trial. Lancet Neurol. 2007 Feb;6(2):115-24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Death from all causes
Secondary	death from vascular causes
Secondary	death from vascular causes or nonfatal stroke
Secondary	fatal or nonfatal stroke
Secondary	death from vascular causes, nonfatal stroke, nonfatal myocardial infarction or vascular intervention
Secondary	major bleeding complications
Secondary	amputations of lower extremities
Secondary	retinal infarction or bleeding