Hexadecasaccharide (SR123781A) in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction

Completed · Phase 2

Conditions studied: Coronary Atherosclerosis

In brief

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.

Key facts

Study ID

NCT00123565

Run by

Sanofi

People needed

1257

Starts

2004-12-01

Expected to finish

2007-05-01

Last updated by the study team

2008-08-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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 who has received heparin during more than 48 hours before inclusion in the study.
• 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.

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States
• Sanofi-Aventis — Buenos Aires, Argentina
• Sanofi-Aventis — Macquarie Park, Australia
• Sanofi-Aventis — Diegem, Belgium
• Sanofi-Aventis — São Paulo, Brazil
• Sanofi-Aventis — Laval, Quebec, Canada
• Sanofi-Aventis — Providencia, Santiago Metropolitan, Chile
• Sanofi-Aventis — Prague, Czechia
• Sanofi-Aventis France — Paris, France
• Sanofi-Aventis — India, India
• Sanofi-Aventis — México, Mexico
• Sanofi-Aventis — Gouda, Netherlands
• Sanofi-Aventis — Warsaw, Poland
• Sanofi-Aventis — Porto Salvo, Portugal
• Sanofi-Aventis — Moscow, Russia
• Sanofi-Aventis — Seoul, South Korea
• Sanofi-aventis — Barcelona, Spain
• Sanofi-Aventis — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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