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

Overview

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.

Full Title of Study: “A Randomized Dose Ranging Study of Hexadecasaccharide Including Active Control, in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction Scheduled to Undergo Percutaneous Coronary Intervention (SHINE)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: May 2007

Interventions

  • Drug: Hexadecasaccharide (SR123781A)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

  • 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.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • ICD Study Director, sanofi-aventis
  • Overall Official(s)
    • ICD CSD, Study Director, Sanofi

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