Journal article
A Randomized Trial Comparing Ticlopidine Hydrochloride with Aspirin for the Prevention of Stroke in High-Risk Patients
The New England journal of medicine, Vol.321(8), pp.501-507
08/24/1989
DOI: 10.1056/NEJM198908243210804
PMID: 2761587
Abstract
We report the results of the Ticlopidine Aspirin Stroke Study, a blinded trial at 56 North American centers that compared the effects of ticlopidine hydrochloride (500 mg daily) with those of aspirin (1300 mg daily) on the risk of stroke or death. The medications were randomly assigned to 3069 patients with recent transient or mild persistent focal cerebral or retinal ischemia. Follow-up lasted for two to six years.
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). Ticlopidine was more effective than aspirin in both sexes.
The adverse effects of aspirin included diarrhea (10 percent), rash (5.5 percent), peptic ulceration (3 percent), gastritis (2 percent), and gastrointestinal bleeding (1 percent). With ticlopidine, diarrhea (20 percent), skin rash (14 percent), and severe but reversible neutropenia (<1 percent) were noted. The mean increase in total cholesterol level was 9 percent with ticlopidine and 2 percent with aspirin (P<0.01). The ratios of high-density lipoprotein and low-density lipoprotein to total cholesterol were similar in both treatment groups.
We conclude that ticlopidine was somewhat more effective than aspirin in preventing strokes in this population, although the risks of side effects were greater. (N Engl J Med 1989; 321:501–7.)
CURRENT treatments to prevent stroke in high-risk patients include vascular surgery, anticoagulants, and platelet antiaggregating drugs
1
,
2
; the value of these therapies remains controversial. Two randomized studies of carotid endarterectomy
3
,
4
have demonstrated no significant reduction in vascular morbidity or mortality, and no benefit has been shown for extracranial-to-intracranial bypass operations.
5
The value of anticoagulant drugs in the prevention of stroke in patients with atherosclerotic disease is also unproved.
6
Dipyridamole does not have any value for the primary prevention of stroke.
7
Since the first anecdotal report of the value of aspirin in preventing stroke,
8
numerous clinical trials have evaluated aspirin's effects . . .
Details
- Title: Subtitle
- A Randomized Trial Comparing Ticlopidine Hydrochloride with Aspirin for the Prevention of Stroke in High-Risk Patients
- Creators
- William K HassJ. Donald EastonHarold P AdamsWilliam Pryse-PhillipsBasil A MolonySharon AndersonBarbara Kamm
- Resource Type
- Journal article
- Publication Details
- The New England journal of medicine, Vol.321(8), pp.501-507
- Publisher
- Massachusetts Medical Society
- DOI
- 10.1056/NEJM198908243210804
- PMID
- 2761587
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- Language
- English
- Date published
- 08/24/1989
- Academic Unit
- Neurology; Iowa Neuroscience Institute
- Record Identifier
- 9984020866902771
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