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Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary Syndrome

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

E5555

Placebo

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome

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
Presenting with features of non-ST segment elevation ACS (unstable angina or Myocardial infarction without persistent ST elevation). and at least one of the following two criteria on admission: Cardiac enzymes≥ ULN for the local institution OR ECG changes compatible with ischemia
Randomisation possible within 24 hours of the onset of the most recent symptomatic episode.

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, history of recent ischemic stroke or transient ischemic attack, or known structural cerebral vascular lesion
Recent trauma, major surgery, Percutaneous coronary intervention or coronary artery surgery
Clinically significant haematological, 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

Beloit Clinic, SC
Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Participants will receive one 50 mg E5555 tablet and two 100 mg placebo tablets, once daily for 12 weeks.

Participants will receive one 50 mg placebo tablet, one 100 mg E5555 tablet, and one 100 mg placebo tablet, once daily for 12 weeks.

Participants will receive one 50 mg placebo tablet and two 100 mg E5555 tablets, once daily for 12 weeks.

Participants will receive one 50 mg placebo tablet and two 100 mg placebo tablets, once daily for 12 weeks.

Outcomes

Primary Outcome Measures

Safety and tolerability

Secondary Outcome Measures

Incidence of Major Adverse Cardiovascular Events; Platelet Aggregation Inhibition; Holter Monitoring. Exploratory Outcome Measure: effects on endovascular inflammatory processes

Full Information

NCT ID

NCT00548587

First Posted

October 22, 2007

Last Updated

January 5, 2016

Sponsor

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00548587

Brief Title

Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary Syndrome

Official Title

A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and Its Effects on Clinical Events and Biomarkers in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eisai Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a multi-center, randomized, double-blind, placebo-controlled study to determine the safety and tolerability of E5555 in subjects with Acute coronary syndrome (ACS).

6. Conditions and Keywords

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

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

600 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Participants will receive one 50 mg E5555 tablet and two 100 mg placebo tablets, once daily for 12 weeks.

Arm Title

Arm Type

Active Comparator

Arm Description

Participants will receive one 50 mg placebo tablet, one 100 mg E5555 tablet, and one 100 mg placebo tablet, once daily for 12 weeks.

Arm Title

Arm Type

Active Comparator

Arm Description

Participants will receive one 50 mg placebo tablet and two 100 mg E5555 tablets, once daily for 12 weeks.

Arm Title

Arm Type

Placebo Comparator

Arm Description

Participants will receive one 50 mg placebo tablet and two 100 mg placebo tablets, once daily for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

E5555

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Safety and tolerability

Time Frame

Up to 16 weeks

Secondary Outcome Measure Information:

Title

Incidence of Major Adverse Cardiovascular Events; Platelet Aggregation Inhibition; Holter Monitoring. Exploratory Outcome Measure: effects on endovascular inflammatory processes

Time Frame

Up to 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA: Males or Females, 45 - 80 years of age Presenting with features of non-ST segment elevation ACS (unstable angina or Myocardial infarction without persistent ST elevation). and at least one of the following two criteria on admission: Cardiac enzymes≥ ULN for the local institution OR ECG changes compatible with ischemia Randomisation possible within 24 hours of the onset of the most recent symptomatic episode. 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, history of recent ischemic stroke or transient ischemic attack, or known structural cerebral vascular lesion Recent trauma, major surgery, Percutaneous coronary intervention or coronary artery surgery Clinically significant haematological, 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

Rafal Ziecina, MD

Organizational Affiliation

Eisai Limited

Official's Role

Study Director

Facility Information:

Facility Name

Beloit Clinic, SC

City

Beloit

State/Province

Wisconsin

ZIP/Postal Code

53511-2230

Country

United States

Facility Name

Royal Brompton Hospital

City

London

ZIP/Postal Code

SW3 6NP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

21502577

Citation

O'Donoghue ML, Bhatt DL, Wiviott SD, Goodman SG, Fitzgerald DJ, Angiolillo DJ, Goto S, Montalescot G, Zeymer U, Aylward PE, Guetta V, Dudek D, Ziecina R, Contant CF, Flather MD; LANCELOT-ACS Investigators. Safety and tolerability of atopaxar in the treatment of patients with acute coronary syndromes: the lessons from antagonizing the cellular effects of Thrombin-Acute Coronary Syndromes Trial. Circulation. 2011 May 3;123(17):1843-53. doi: 10.1161/CIRCULATIONAHA.110.000786. Epub 2011 Apr 18.

Results Reference

derived

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Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary Syndrome

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