The primary purpose of this study is to assess the safety and tolerability of E5555 in subjects with coronary artery disease.
This was a multicenter, randomized, double-blind, placebo-controlled trial of E5555, a PAR-1 inhibitor. The total duration of individual study participation was 28 weeks (196 days). This included a treatment period of 24 weeks (168 days) and a follow-up period of 4 weeks (28 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
720
Florida Research Network
Gainesville, Florida, United States
Great Lakes Heart Center of Alpena
Alpena, Michigan, United States
Safety and tolerability - especially the risk of bleeding
Time frame: 6 months
Incidence of major adverse cardiovascular events; the effect on platelet aggregation inhibition. Exploratory Outcome Measure: effects on endovascular inflammatory processes
Time frame: 6 months
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