NCT00548587

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).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2007

Geographic Reach
2 countries

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

Study Start

First participant enrolled

October 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

February 4, 2016

Status Verified

November 1, 2015

Enrollment Period

1.5 years

First QC Date

October 22, 2007

Last Update Submit

January 5, 2016

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    Up to 16 weeks

Secondary Outcomes (1)

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

    Up to 16 weeks

Study Arms (4)

1

ACTIVE COMPARATOR

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

Drug: E5555Drug: Placebo

2

ACTIVE COMPARATOR

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

Drug: E5555Drug: Placebo

3

ACTIVE COMPARATOR

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

Drug: E5555Drug: Placebo

4

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

E5555DRUG
123
PlaceboDRUG
1234

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
  • 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.

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, 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beloit Clinic, SC

Beloit, Wisconsin, 53511-2230, United States

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 21502577DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

E 5555

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Rafal Ziecina, 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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2007

First Posted

October 24, 2007

Study Start

October 1, 2007

Primary Completion

April 1, 2009

Study Completion

August 1, 2009

Last Updated

February 4, 2016

Record last verified: 2015-11

Locations

US(1)GB(1)