NCT00123565

Brief Summary

The purpose of this study is to test whether SR123781A is a possible treatment for patients with acute coronary syndromes (heart attack) who are scheduled to undergo a percutaneous coronary intervention (PCI) within 48 hours after inclusion in the study. Two doses of SR123781A are currently tested, each in a group of about 180 patients per group to find which is the most adequate, versus heparin and glycoprotein IIbIIIa (GPIIBIIIA) antagonist.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
1,257

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2004

Geographic Reach
18 countries

18 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

December 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

August 21, 2008

Status Verified

August 1, 2008

Enrollment Period

2.4 years

First QC Date

July 22, 2005

Last Update Submit

August 20, 2008

Conditions

Coronary Atherosclerosis

Keywords

Coronary Disease

Outcome Measures

Primary Outcomes (1)

  • Efficacy: composite of all causes of death, new myocardial infarction, or severe myocardial ischemia requiring urgent repeat target vessel revascularization within 7 days following randomization.

Secondary Outcomes (1)

  • Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group.

Interventions

Hexadecasaccharide (SR123781A)DRUG

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A person with a diagnosis of acute coronary syndrome who is scheduled to undergo a PCI within 48 hours.
  • A person who is of the legal age of 21, who is mentally competent, and who has signed a written informed consent

You may not qualify if:

  • A person with known allergy or any contra-indication to active control.
  • A person treated with warfarin (oral anticoagulant).
  • A person with current bleeding or recognized increased risk of bleeding or history of intracranial hemorrhage.
  • A person who has had a stroke within the last 6 months.
  • A person with uncontrolled hypertension despite antihypertensive therapy.
  • A person with history of clinically significant reduction in blood platelets or neutrophils (white blood cells).
  • A person who has laboratory evidence of significantly reduced renal function or who is dependent on renal dialysis.
  • A person who has a coronary bypass performed during the previous month.
  • A pregnant or nursing woman or a woman of childbearing potential (before menopause) who does not have a negative pregnancy test and does not use a reliable method of birth control.
  • A person who has received any investigational treatment in the preceding month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Sanofi-Aventis

Bridgewater, New Jersey, United States

Location

Sanofi-Aventis

Buenos Aires, 1642, Argentina

Location

Sanofi-Aventis

Macquarie Park, NSW 2113, Australia

Location

Sanofi-Aventis

Diegem, 18 31, Belgium

Location

Sanofi-Aventis

São Paulo, 05677-000, Brazil

Location

Sanofi-Aventis

Laval, Quebec, H7L 4A8, Canada

Location

Sanofi-Aventis

Providencia, Santiago Metropolitan, Chile

Location

Sanofi-Aventis

Prague, 160 00, Czechia

Location

Sanofi-Aventis France

Paris, France

Location

Sanofi-Aventis

India, India

Location

Sanofi-Aventis

México, 04000, Mexico

Location

Sanofi-Aventis

Gouda, 2803 PE, Netherlands

Location

Sanofi-Aventis

Warsaw, 02-672, Poland

Location

Sanofi-Aventis

Porto Salvo, 2740-244, Portugal

Location

Sanofi-Aventis

Moscow, 103045, Russia

Location

Sanofi-Aventis

Seoul, South Korea

Location

Sanofi-aventis

Barcelona, 08019, Spain

Location

Sanofi-Aventis

Istanbul, 34 394, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Disease

Interventions

SR 123781A

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 22, 2005

First Posted

July 25, 2005

Study Start

December 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

August 21, 2008

Record last verified: 2008-08

Locations

FR(1)BR(1)ES(1)TU(1)CL(1)IN(1)ME(1)BE(1)PT(1)NL(1)AR(1)CZ(1)KR(1)US(1)PL(1)AU(1)RU(1)CA(1)