drugset / Trial / NCT00161070

ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

NCT00161070 ↗

Phase 4 Completed 4500 enrolled UMC Utrecht
RandomizedParallel-groupOpen-labelPrevention

Summary

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.

Timeline

Start
1997-07
Primary completion
—
Completion
2006-12

Outcome

Mixed primary results

paper Primary outcome events arose in 173 (13%) patients on aspirin and dipyridamole and in 216 (16%) on aspirin alone (hazard ratio 0.80, 95% CI 0.66-0.98; PMID 16714187 ↗

paper A primary outcome event occurred in 99 (19%) patients on anticoagulants and in 98 (18%) patients on aspirin (hazard ratio [HR] 1.02, 95% CI 0.77-1.35). PMID 17239798 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 30 mg —
Subject Aspirin Small molecule 325 mg —
Subject Dipyridamole Other / unclassified 200 mg —