Transient Ischemic Attack Clinical Trial
Official title:
ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial
The objective of ESPRIT was to compare the efficacy and safety of mild anticoagulation or a combination treatment of aspirin and dipyridamole with the efficacy and safety of treatment with aspirin alone after cerebral ischemia of arterial origin.
Low-dose aspirin (ASA) (at least 30 mg/day) prevents only 13% of subsequent vascular events
after minor cerebral ischemia of arterial origin. Anticoagulation (AC) has been proven
highly effective in preventing vascular events after myocardial infarction and after
cerebral ischemia in patients with atrial fibrillation. A previous study on the effects of
AC after cerebral ischemia of arterial origin (SPIRIT) showed that high intensity AC (INR
3.0 to 4.5) is not safe, but that mild AC (INR 2.0 to 3.0) was. The 2nd European Stroke
Prevention Trial (ESPS-2) reported a 22% relative risk reduction of the combination of ASA
and dipyridamole (DIP) above that of ASA only; its results, however, are subject to debate.
Study design: ESPRIT was an open randomised controlled trial allocating patients who
experienced a transient ischemic attack (TIA) or a non-disabling ischemic stroke to either:
A. oral AC (INR 2.0 to 3.0);
B. the combination of DIP (400 mg daily) plus ASA (30-325 mg/day); or
C. ASA only (same dose).
The mean follow-up was three years. Primary outcome was the composite of vascular death,
stroke, myocardial infarction or major bleeding. Outcome assessment is blind.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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