ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial - Full Text View

Sponsor:	UMC Utrecht
Information provided by:	UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00161070

Purpose

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.

Condition	Intervention	Phase
Brain Ischemia Transient Ischemic Attack Arteriosclerosis	Drug: anticoagulation Drug: aspirin and dipyridamole Drug: aspirin alone	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Transient Ischemic Attack

Drug Information available for: Acetylsalicylic acid Dipyridamole

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	4500
Study Start Date:	July 1997
Study Completion Date:	December 2006

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161070

Locations

Netherlands
UMC Utrecht
Utrecht, Netherlands

Sponsors and Collaborators

UMC Utrecht

Investigators

Principal Investigator:	A. Algra, Professor	UMC Utrecht
Principal Investigator:	J. Gijn Van, Professor	UMC Utrecht

More Information

Publications:

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.

The ESPRIT Study Group; 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.

Study ID Numbers:	96-217, Heart Found.: 97.026, Eur. Com.: QLK6-CT-2002-02332
Study First Received:	September 8, 2005
Last Updated:	March 21, 2007
ClinicalTrials.gov Identifier:	NCT00161070 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:

secondary prevention
TIA / minor stroke
atherosclerotic origin
TIA (Transient Ischemic Attack)
prevention & control

Additional relevant MeSH terms:

Peripheral Nervous System Agents
Sensory System Agents
Hematologic Agents
Physiological Effects of Drugs
Antirheumatic Agents
Platelet Aggregation Inhibitors
Cardiovascular Agents
Vasodilator Agents
Anti-Inflammatory Agents
Central Nervous System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Anti-Inflammatory Agents, Non-Steroidal
Molecular Mechanisms of Pharmacological Action
Arteriosclerosis

Brain Diseases
Cerebrovascular Disorders
Pathologic Processes
Aspirin
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Analgesics
Arterial Occlusive Diseases
Ischemic Attack, Transient
Cyclooxygenase Inhibitors
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors

ClinicalTrials.gov processed this record on November 20, 2009