Stroke Trials Registry

Ticlopidine Aspirin Stroke Study

Principal Investigator
William K. Hass

PI Address
New York University Medical Center, Department of Neurology, NY 10016.

Contact Address
Dr. Hass, Department of Neurology, New York University Medical Center, 550 First Ave., New York, NY 10016.

Sponsor

Study Size Actual:	3069
Centers Actual:	56

Status:
Trial complete. Results published 8/89.

Purpose:
To compare the effects of ticlopidine hydrochloride with those of aspirin on the risk of recurrent stroke or death.

Interventions:

Aspirin (stroke prevention)
Antiplatelet agent; inhibits thromboxane A2

Ticlopidine
Antiplatelet agent.

Location(s):
America

Year Started: 1982

Year Finished: 1986

Year Published: 1989

Design:
Randomized, stratified, double-blind trial of 3069 patients at 56 centers in the U.S. and Canada. Patients were stratified at each center by history of ischemic cardiovascular disease, the occurrence of a moderate or major stroke more than three months before entry, and sex.

Inclusion Criteria
One or more of the following within 3 months of entry: transient ischemic attack (a focal ischemic cerebrovascular event lasting less than 24 hours and followed by complete recovery); amaurosis fugax (a unilateral ischemic retinal episode lasting less than 24 hours); reversible ischemic neurologic deficit (a focal ischemic cerebrovascular event lasting more than 24 hours but less than three weeks and followed by complete recovery); minor stroke (a focal ischemic cerebrovascular event resulting in minimal permanent neurologic deficit and at least 80 % recovery of function within 3 weeks).

Exclusion Criteria
Women with childbearing potential; symptoms due to migraine, cardiogenic embolism, or hematologic disorders; history of peptic ulcer disease, upper gastrointestinal bleeding, or life-threatening diseases such as cancer; previous hypersensitivity or intolerance to aspirin; need for continued use of aspirin or anticoagulants.

Patient Involvement:
Patients were randomized to receive ticlopidine hydrochloride (250 mg twice daily) or aspirin (650 mg twice daily). Treatment was continued until the end of the trial (mean of 778 +/- 603 days in the ticlopidine group and 858 +/- 582 days in the aspirin group). Patients were evaluated one month after randomization and then at four-month intervals until the end of the trial.

Primary Outcome:
Nonfatal stroke or death from all causes.

Secondary Outcome:
Composite of fatal and nonfatal strokes.

Results:
The three-year event rate for nonfatal stroke or death from any cause was 17 percent for ticlopidine and 19 percent for aspirin--a 12 percent risk reduction (95 percent confidence interval, -2 to 26 percent) with ticlopidine (P = 0.048 for cumulative Kaplan-Meier estimates). The rates of fatal and nonfatal stroke at three years were 10 percent for ticlopidine and 13 percent for aspirin--a 21 percent risk reduction (95 percent confidence interval, 4 to 38 percent) with ticlopidine (P = 0.024 for cumulative Kaplan-Meier estimates).

Source of Information:
Published reports.

Web Links and Publications:

Efficacy of ticlopidine and aspirin for prevention of reversible cerebrovascular ischemic events. The Ticlopidine Aspirin Stroke Study.
Stroke 1993 Oct;24(10):1452-1457

Prevention of stroke with ticlopidine: who benefits most? TASS Baseline and Angiographic Data Subgroup.
Neurology. 1992 Jan;42(1):111-5.

Ticlopidine versus aspirin for the prevention of recurrent stroke. Analysis of patients with minor stroke from the Ticlopidine Aspirin Stroke Study.
Stroke 1992 Dec;23(12):1723-1727

A randomized trial comparing ticlopidine hydrochloride with aspirin for the prevention of stroke in high-risk patients. Ticlopidine Aspirin Stroke Study Group.
N Engl J Med 1989 Aug 24;321(8):501-507

This information last updated on: 10/19/2001

UID: 373