Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease

Study Overview
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Brief Summary
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The primary purpose of this study is to assess the safety and tolerability of E5555 in subjects with coronary artery disease.

Detailed Description
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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).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: E5555
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E5555 50 mg<br>Participants received one 50 mg E5555 and two 100 mg placebo tablets, once orally daily for 24 weeks. | Drug: E5555<br>* 50 mg or 100 mg E5555 tablets<br>Drug: Placebo<br>* 50 mg and/or 100 mg placebo tablets<br>|
| Experimental: E5555 100 mg<br>Participants received one 50 mg placebo, one 100 mg E5555 and one 100 mg placebo tablets, once orally daily for 24 weeks. | Drug: E5555<br>* 50 mg or 100 mg E5555 tablets<br>Drug: Placebo<br>* 50 mg and/or 100 mg placebo tablets<br>|
| Active Comparator: E5555 200 mg<br>Participants received one 50 mg placebo and two 100 mg E5555 tablets were taken orally once daily for 24 weeks. | Drug: E5555<br>* 50 mg or 100 mg E5555 tablets<br>Drug: Placebo<br>* 50 mg and/or 100 mg placebo tablets<br>|
| Placebo Comparator: Placebo<br>Participants received one 50 mg placebo and two 100 mg placebo tablets, once orally daily for 24 weeks. | Drug: Placebo<br>* 50 mg and/or 100 mg placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability - especially the risk of bleeding |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse cardiovascular events; the effect on platelet aggregation inhibition. Exploratory Outcome Measure: effects on endovascular inflammatory processes |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease