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

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)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Atherosclerosis
• Intervention / Treatment: Drug: Hexadecasaccharide (SR123781A)

• Study Type: Interventional
• Enrollment (Actual): 1257
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1642
    • Sanofi-Aventis
• Australia
  • Macquarie Park, Australia, NSW 2113
    • Sanofi-Aventis
• Belgium
  • Diegem, Belgium, 18 31
    • Sanofi-Aventis
• Brazil
  • Sao Paulo, Brazil, 05677-000
    • Sanofi-Aventis
• Canada
  • Quebec
    • Laval, Quebec, Canada, H7L 4A8
      • Sanofi-Aventis
• Chile
  • Santiago
    • Providencia, Santiago, Chile
      • Sanofi-Aventis
• Czech Republic
  • Praha, Czech Republic, 160 00
    • Sanofi-Aventis
• France
  • Paris, France
    • Sanofi-Aventis France
• India
  • India, India
    • Sanofi-Aventis
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Sanofi-Aventis
• Mexico
  • Mexico, Mexico, 04000
    • Sanofi-Aventis
• Netherlands
  • Gouda, Netherlands, 2803 PE
    • Sanofi-Aventis
• Poland
  • Warszawa, Poland, 02-672
    • Sanofi-Aventis
• Portugal
  • Porto Salvo, Portugal, 2740-244
    • Sanofi-Aventis
• Russian Federation
  • Moscow, Russian Federation, 103045
    • Sanofi-Aventis
• Spain
  • Barcelona, Spain, 08019
    • Sanofi-Aventis
• Turkey
  • Istanbul, Turkey, 34 394
    • Sanofi-Aventis
• United States
  • New Jersey
    • Bridgewater, New Jersey, United States
      • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: July 22, 2005
• First Submitted That Met QC Criteria: July 22, 2005
• First Posted (Estimate): July 25, 2005

Study Record Updates

• Last Update Posted (Estimate): August 21, 2008
• Last Update Submitted That Met QC Criteria: August 20, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Coronary Disease
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Angina Pectoris; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Angina, Unstable
• Other Study ID Numbers: DRI5228; SR123781A