Clinical trial NCT00312052: Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2006-04-07
Enrollment: 720
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Safety and tolerability - especially the risk of bleeding
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of major adverse cardiovascular events; the effect on platelet aggregation inhibition. Exploratory Outcome Measure: effects on endovascular inflammatory processes
timeFrame: 6 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Florida Research Network
state: Florida
city: Alpena
country: United States
facility: Great Lakes Heart Center of Alpena
state: Michigan
Study officials:
affiliation: Eisai Limited
name: John Riefler, MD
role: STUDY_DIRECTOR
References:
citation: Wiviott SD, Flather MD, O'Donoghue ML, Goto S, Fitzgerald DJ, Cura F, Aylward P, Guetta V, Dudek D, Contant CF, Angiolillo DJ, Bhatt DL; LANCELOT-CAD Investigators. Randomized trial of atopaxar in the treatment of patients with coronary artery disease: the lessons from antagonizing the cellular effect of Thrombin-Coronary Artery Disease Trial. Circulation. 2011 May 3;123(17):1854-63. doi: 10.1161/CIRCULATIONAHA.110.001404. Epub 2011 Apr 18.