Anticoagulation and aspirin and dipyridamole and aspirin alone in Arteriosclerosis and Brain Ischemia and Transient Ischemic Attack - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

4500

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- - Utrecht, Netherlands
    - UMC Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1997

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria