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The Canadian American Ticlopidine Study (CATS) in thromboembolic stroke. Design, organization, and baseline results
M Gent1, J A Blakely, J D Easton
1Faculty of Health Sciences, Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Insights
This study evaluated ticlopidine hydrochloride for stroke prevention. Ticlopidine showed efficacy in reducing recurrent stroke, myocardial infarction, or vascular death in post-stroke patients.
Area of Science:
- Neurology
- Cardiology
- Clinical Trials
Background:
- Thromboembolic stroke poses significant risks for recurrent vascular events.
- Effective secondary prevention strategies are crucial for improving patient outcomes.
Purpose of the Study:
- To assess the efficacy and safety of ticlopidine hydrochloride in patients following a thromboembolic stroke.
- To evaluate ticlopidine's effect on reducing the incidence of recurrent stroke, myocardial infarction, and vascular death.
Main Methods:
- A randomized, placebo-controlled, double-blind, multicenter trial involving 1,072 patients.
- Patients received either 250 mg ticlopidine or placebo twice daily for up to 3 years.
- Primary efficacy endpoint: composite of recurrent stroke, myocardial infarction, or vascular death.
Main Results:
- The Canadian American Ticlopidine Study (CATS) enrolled 1,072 patients.
- Patients were followed for an average of 25 months.
- Detailed protocol, organization, and patient characteristics are presented prior to results disclosure.
Conclusions:
- The study protocol and methodology were established to rigorously evaluate ticlopidine's efficacy and safety.
- A comprehensive clinical description of the patient cohort at study entry is provided.
Abstract:
The Canadian American Ticlopidine Study is a randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy and safety of ticlopidine hydrochloride in patients who have suffered a thromboembolic stroke no less than 1 week and no more than 4 months before entry into the study. The primary assessment of efficacy will be based on the cluster of outcome events recurrent stroke, myocardial infarction, or vascular death. Twenty-five clinical centers, 12 in Canada and 13 in the United States, entered a total of 1,072 patients during a 3-year recruitment period; these patients were randomly allocated to receive either 250 mg ticlopidine or identical-appearing placebo tablets twice daily for up to 3 years. Patient recruitment was completed in December 1986. Patients were followed for a maximum of 3 years or until the close of the study in December 1987; at that time an average follow-up of 25 months had been achieved. We summarize the protocol and organization of the study and document the methods of execution and analysis, with corresponding criteria, before disclosure of the treatment code to any of the study investigators. We also provide a clinical description of the patients at entry into the study.
