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

Eisai

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease

Treatments: Drug: E5555; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00312052

E5555-G000-201

2005-006029-94 (EudraCT Number)

Details and patient eligibility

About

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

Full 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).

Enrollment: 720 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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720 participants in 4 patient groups, including a placebo group

E5555 50 mg

Experimental group

Description:

Participants received one 50 mg E5555 and two 100 mg placebo tablets, once orally daily for 24 weeks.

Treatment:

Drug: E5555

Drug: Placebo

E5555 100 mg

Experimental group

Description:

Participants received one 50 mg placebo, one 100 mg E5555 and one 100 mg placebo tablets, once orally daily for 24 weeks.

Treatment:

Drug: E5555

Drug: Placebo

E5555 200 mg

Active Comparator group

Description:

Participants received one 50 mg placebo and two 100 mg E5555 tablets were taken orally once daily for 24 weeks.

Treatment:

Drug: E5555

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Participants received one 50 mg placebo and two 100 mg placebo tablets, once orally daily for 24 weeks.

Treatment:

Drug: Placebo