Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease
Study Details
Study Description
Brief Summary
The primary purpose of this study is to assess the safety and tolerability of E5555 in subjects with coronary artery disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: E5555 50 mg Participants received one 50 mg E5555 and two 100 mg placebo tablets, once orally daily for 24 weeks. |
Drug: E5555
50 mg or 100 mg E5555 tablets
Drug: Placebo
50 mg and/or 100 mg placebo tablets
|
| Experimental: E5555 100 mg Participants received one 50 mg placebo, one 100 mg E5555 and one 100 mg placebo tablets, once orally daily for 24 weeks. |
Drug: E5555
50 mg or 100 mg E5555 tablets
Drug: Placebo
50 mg and/or 100 mg placebo tablets
|
| Active Comparator: E5555 200 mg Participants received one 50 mg placebo and two 100 mg E5555 tablets were taken orally once daily for 24 weeks. |
Drug: E5555
50 mg or 100 mg E5555 tablets
Drug: Placebo
50 mg and/or 100 mg placebo tablets
|
| Placebo Comparator: Placebo Participants received one 50 mg placebo and two 100 mg placebo tablets, once orally daily for 24 weeks. |
Drug: Placebo
50 mg and/or 100 mg placebo tablets
|
Outcome Measures
Primary Outcome Measures
- Safety and tolerability - especially the risk of bleeding [6 months]
Secondary Outcome Measures
- Incidence of major adverse cardiovascular events; the effect on platelet aggregation inhibition. Exploratory Outcome Measure: effects on endovascular inflammatory processes [6 months]
Eligibility Criteria
Criteria
INCLUSION CRITERIA:
-
Males or Females, 45 - 80 years of age
-
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
- All subjects must be receiving low dose aspirin and/or clopidogrel and/or ticlopidine.
EXCLUSION CRITERIA
-
History of acquired or congenital bleeding disorder, coagulopathy or platelet disorder, or history of pathological bleeding within the last 6 months
-
History of intracranial bleeding, history of hemorrhagic retinopathy or known structural cerebral vascular lesion
-
Clinically significant hematological, hepatic or renal abnormalities
-
Patients with some specific ST-segment changes, severe congestive heart failure or uncontrolled cardiac arrhythmias at baseline
-
Recent significant (as determined by the investigator) cardiovascular events
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florida Research Network | Gainesville | Florida | United States | 32605 |
| 2 | Great Lakes Heart Center of Alpena | Alpena | Michigan | United States | 49707 |
Sponsors and Collaborators
- Eisai Inc.
Investigators
- Study Director: John Riefler, MD, Eisai Limited
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E5555-G000-201
- 2005-006029-94