NCT00312052

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for phase_2 coronary-artery-disease

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2006

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

December 5, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

April 5, 2006

Last Update Submit

December 1, 2016

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability - especially the risk of bleeding

    6 months

Secondary Outcomes (1)

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

    6 months

Study Arms (4)

E5555 50 mg

EXPERIMENTAL

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

Drug: E5555Drug: Placebo

E5555 100 mg

EXPERIMENTAL

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

Drug: E5555Drug: Placebo

E5555 200 mg

ACTIVE COMPARATOR

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

Drug: E5555Drug: Placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

E5555DRUG

50 mg or 100 mg E5555 tablets

E5555 100 mgE5555 200 mgE5555 50 mg
PlaceboDRUG

50 mg and/or 100 mg placebo tablets

E5555 100 mgE5555 200 mgE5555 50 mgPlacebo

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Florida Research Network

Gainesville, Florida, 32605, United States

Location

Great Lakes Heart Center of Alpena

Alpena, Michigan, 49707, United States

Location

Related Publications (1)

  • 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.

    PMID: 21502571DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

E 5555

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • John Riefler, MD

    Eisai Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2006

First Posted

April 7, 2006

Study Start

September 1, 2007

Primary Completion

March 1, 2008

Study Completion

August 1, 2009

Last Updated

December 5, 2016

Record last verified: 2016-11

Locations

US(2)