Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease
Brief summary
The primary purpose of this study is to assess the safety and tolerability of E5555 in subjects with coronary artery disease.
Detailed description
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).
Interventions
DRUGE5555
50 mg or 100 mg E5555 tablets
DRUGPlacebo
50 mg and/or 100 mg placebo tablets
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Males or Females, 45 - 80 years of age 2. Confirmed coronary artery disease defined as one of the following: * Post-acute coronary syndrome or myocardial infarction or * Post percutaneous coronary intervention or coronary artery bypass graft or oAngina pectoris with documented (electrocardiogram or imaging study) ischemia or * Angiographically documented lesion occluding ≥70% of a coronary vessel And at high risk as defined as one or more of the following: * Elevated hsCRP (high-sensitivity C-reactive protein) * Diabetes mellitus * History of carotid artery disease and/or peripheral artery disease * Thrombo-embolic transient ischemic attack or stroke \>1 year prior to screening 3. All subjects must be receiving low dose aspirin and/or clopidogrel and/or ticlopidine.
Exclusion criteria
1. History of acquired or congenital bleeding disorder, coagulopathy or platelet disorder, or history of pathological bleeding within the last 6 months 2. History of intracranial bleeding, history of hemorrhagic retinopathy or known structural cerebral vascular lesion 3. Clinically significant hematological, hepatic or renal abnormalities 4. Patients with some specific ST-segment changes, severe congestive heart failure or uncontrolled cardiac arrhythmias at baseline 5. Recent significant (as determined by the investigator) cardiovascular events
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability - especially the risk of bleeding | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of major adverse cardiovascular events; the effect on platelet aggregation inhibition. Exploratory Outcome Measure: effects on endovascular inflammatory processes | 6 months |
Countries
United States
Outcome results
None listed