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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312052
• Other study ID #: E5555-G000-201
• Secondary ID: 2005-006029-94
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2006
• Last updated: December 1, 2016
• Start date: September 2007
• Est. completion date: August 2009

Study information

• Verified date: November 2016
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: August 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Inflammation
• Myocardial Ischemia

Intervention

Drug:
• E5555
50 mg or 100 mg E5555 tablets
• Placebo
50 mg and/or 100 mg placebo tablets

Locations

Country	Name	City	State
United States	Great Lakes Heart Center of Alpena	Alpena	Michigan
United States	Florida Research Network	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability - especially the risk of bleeding		6 months	Yes
Secondary	Incidence of major adverse cardiovascular events; the effect on platelet aggregation inhibition. Exploratory Outcome Measure: effects on endovascular inflammatory processes		6 months	Yes