Stroke Trials Registry

AITIA
Aspirin in Transient Ischemic Attacks

Principal Investigator
WS Fields

PI Address
University of Texas Health Science Center, Houston, TX.

Contact Address
Dr. W. S. Fields, 6301 Alameda, Houston, TX 77021.

Sponsor

Study Size Actual:	303
Centers Actual:	10
Max Time from onset:	3 Months

Status:
Trial complete. Results published 5/77.

Purpose:
To determine whether aspirin has a clinical benefit in the prevention of arterial thromboembolism and its consequences.

Interventions:

Aspirin (stroke prevention)
Antiplatelet agent; inhibits thromboxane A2

Location(s):
Winston-Salem, NC; Indianapolis, IN, New York, NY; San Francisco, CA; Birmingham, AL; Cincinnati, OH; Rochester, NY; Charlottesville, VA; Detroit, MI

Year Published: 1977

Design:
Double-blind, placebo-controlled, multicenter trial of 303 patients at 10 centers.

Inclusion Criteria
Carotid territory TIA within 3 months of entry.

Exclusion Criteria
Ill-defined symptoms, severe neurological deficits, non-lateralized symptoms.

Patient Involvement:
Assignment into the medical and surgical groups was made by the responsible physician based on the patients' baseline clinical and laboratory evaluation. Each group was then independently randomized (after surgery in the surgical group). Patients randomized to aspirin received 650 mg twice daily. Blinded follow-up evaluations were done at 4-week intervals during the first 6 months following hospital discharge and every 3 months thereafter through 24 months. At each follow-up visit, the patient was interviewed and examined by a neurologist and blood, urine, and stool tests were performed.

Primary Outcome:
Overall mortality, stroke-related mortality, retinal infarction, nonfatal cerebral infarction.

Secondary Outcome:
TIAs pre- and post-randomization.

Results:
Analysis of the 189 patients who had not undergone carotid surgery prior to randomization revealed no difference in the cumulative probabilities of mortality, cerebral infarction and retinal infarction between the two treatment groups (p=0.18). When cases with insufficient follow-up were excluded and the number of TIAs pre and post-randomization were compared, there was a significant differential in favor of aspirin (p=0.04). Analysis of the 128 patients in the surgical group did not reveal a significant difference in the cumulative probabilities of mortality, cerebral infarction and retinal infarction. Life table analyses that eliminated non stroke-related deaths revealed a significant difference in favor of aspirin.

Source of Information:
Published reports 1977.

Web Links and Publications:

Controlled trial of aspirin in cerebral ischemia: an addendum.
Neurology 1986 May;36(5):705-10.

Controlled trial of aspirin in cerebral ischemia.
Circulation 1980 Dec;62(6 Pt 2):V90-6.

Controlled trial of aspirin in cerebral ischemia. Part II: surgical group.
Stroke 1978 Jul-Aug;9(4):309-19.

Controlled trial of aspirin in cerebral ischemia.
Stroke 1977 May-Jun;8(3):301-14.

This information last updated on: 4/5/2001

UID: 241