MedDataX Logo

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

NCT ID: NCT00312052

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

E5555 50 mg

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

Group Type EXPERIMENTAL

E5555

Intervention Type DRUG

50 mg or 100 mg E5555 tablets

Placebo

Intervention Type DRUG

50 mg and/or 100 mg placebo tablets

E5555 100 mg

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

Group Type EXPERIMENTAL

E5555

Intervention Type DRUG

50 mg or 100 mg E5555 tablets

Placebo

Intervention Type DRUG

50 mg and/or 100 mg placebo tablets

E5555 200 mg

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

Group Type ACTIVE_COMPARATOR

E5555

Intervention Type DRUG

50 mg or 100 mg E5555 tablets

Placebo

Intervention Type DRUG

50 mg and/or 100 mg placebo tablets

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

50 mg and/or 100 mg placebo tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

E5555

50 mg or 100 mg E5555 tablets

Intervention Type DRUG

Placebo

50 mg and/or 100 mg placebo tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John Riefler, MD

Role: STUDY_DIRECTOR

Eisai Limited

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Florida Research Network

Gainesville, Florida, United States

Site Status

Great Lakes Heart Center of Alpena

Alpena, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21502571 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2005-006029-94

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

E5555-G000-201

Identifier Type: -

Identifier Source: org_study_id