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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00123565
Recruitment Status : Completed
First Posted : July 25, 2005
Last Update Posted : August 21, 2008
Sponsor:
Information provided by:
Sanofi

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.

Condition or disease Intervention/treatment Phase
Coronary Atherosclerosis Drug: Hexadecasaccharide (SR123781A) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1257 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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 Start Date : December 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine





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


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123565


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

Additional Information:
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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00123565    
Other Study ID Numbers: DRI5228
SR123781A
First Posted: July 25, 2005    Key Record Dates
Last Update Posted: August 21, 2008
Last Verified: August 2008
Keywords provided by Sanofi:
Coronary Disease
Additional relevant MeSH terms:
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Myocardial Infarction
Atherosclerosis
Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Coronary Disease