ESPS 2

ESPS 2 was a multicentre, randomised, double-blind, placebo-controlled, 2 x 2 factorial design large-scale trial involving 6,602 patients enroled through 59 centres throughout Europe. The study drugs were extended-release dipyridamole 200 mg plus ASA 25 mg, bid vs. placebo, bid. Inclusion of a placebo group was critical to determine the independent efficacies of ASA and ER-DP at the doses used to access tolerability. The placebo group was approved by the Ethics Committees of the individual study centres and by an international Study Ethics Committee at the time ESPS 2 was designed. The factorial design provided statistical power for evaluation of individual drug effects and for the comparison of individual treatment groups. Follow-up consisted of examinations at 1 month, 3 months, and then every 3 months for 2 years, regardless of compliance with the study protocol. The primary endpoints were fatal/non-fatal stroke, death from any cause, stroke and/or death. Secondary endpoints were TIA, MI, vascular events (APT definition: vascular death, non-fatal stroke, non-fatal myocardial infarction), OVE (other vascular events: deep venous thrombosis, pulmonary embolism, peripheral arterial obstruction, venous retinal events).