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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
E5555
Placebo
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida Research Network
  • Great Lakes Heart Center of Alpena

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

E5555 50 mg

E5555 100 mg

E5555 200 mg

Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Safety and tolerability - especially the risk of bleeding

Secondary Outcome Measures

Incidence of major adverse cardiovascular events; the effect on platelet aggregation inhibition. Exploratory Outcome Measure: effects on endovascular inflammatory processes

Full Information

First Posted
April 5, 2006
Last Updated
December 1, 2016
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00312052
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.

4. Oversight

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
720 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E5555 50 mg
Arm Type
Experimental
Arm Description
Participants received one 50 mg E5555 and two 100 mg placebo tablets, once orally daily for 24 weeks.
Arm Title
E5555 100 mg
Arm Type
Experimental
Arm Description
Participants received one 50 mg placebo, one 100 mg E5555 and one 100 mg placebo tablets, once orally daily for 24 weeks.
Arm Title
E5555 200 mg
Arm Type
Active Comparator
Arm Description
Participants received one 50 mg placebo and two 100 mg E5555 tablets were taken orally once daily for 24 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received one 50 mg placebo and two 100 mg placebo tablets, once orally daily for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
E5555
Intervention Description
50 mg or 100 mg E5555 tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
50 mg and/or 100 mg placebo tablets
Primary Outcome Measure Information:
Title
Safety and tolerability - especially the risk of bleeding
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence of major adverse cardiovascular events; the effect on platelet aggregation inhibition. Exploratory Outcome Measure: effects on endovascular inflammatory processes
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Riefler, MD
Organizational Affiliation
Eisai Limited
Official's Role
Study Director
Facility Information:
Facility Name
Florida Research Network
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Great Lakes Heart Center of Alpena
City
Alpena
State/Province
Michigan
ZIP/Postal Code
49707
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21502571
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.
Results Reference
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Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease

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