Key result
The Dutch TIA trial is a double-blind randomized clinical trial designed to evaluate 30 mg vs 300 mg aspirin and 50 mg atenolol vs placebo on death and disability in at least 2,500 patients.
Why the study?
Does low-dose aspirin (30 mg vs 300 mg) and atenolol (50 mg vs placebo) reduce death and disability in patients with transient ischemic attacks or nondisabling stroke?
RCT (n=2,500)
double-blind
double randomization
Yes
Does low-dose aspirin (30 mg vs 300 mg) and atenolol (50 mg vs placebo) reduce death and disability in patients with transient ischemic attacks or nondisabling stroke?
This paper describes the design of the Dutch TIA trial evaluating low-dose aspirin and atenolol in patients with TIA or nondisabling stroke.
We describe the background, design, and organization of a double-blind clinical trial in patients with transient ischemic attacks or nondisabling stroke in more than 60 hospitals in The Netherlands. Two different therapeutic comparisons are made by double randomization: 30 mg vs. 300 mg acetylsalicylic acid, and 50 mg atenolol vs. placebo. For the diagnosis, a checklist has been used on which the time course and the nature of the symptoms are recorded in plain language. The analysis will primarily assess death and disability from all causes, with disability measured using a modified Rankin scale. Secondary end points will be vascular death, nonfatal stroke, nonfatal myocardial infarction, and retinal infarction. The study will last for a minimum of 3 years and should involve at least 2,500 patients. More than 1,100 patients were randomized in the 1st year.
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A 1988 study conducted an RCT in transient ischemic attacks or nondisabling stroke (n=2,500). acetylsalicylic acid and atenolol vs. 300 mg acetylsalicylic acid; placebo was evaluated on death and disability from all causes. The Dutch TIA trial is a double-blind randomized clinical trial designed to evaluate 30 mg vs 300 mg aspirin and 50 mg atenolol vs placebo on death and disability in at least 2,500 patients.
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