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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00123565
First received: July 22, 2005
Last updated: August 20, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Coronary Atherosclerosis
Drug: Hexadecasaccharide (SR123781A)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

Enrollment: 1257
Study Start Date: December 2004
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123565

  Show 18 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00123565     History of Changes
Other Study ID Numbers: DRI5228, SR123781A
Study First Received: July 22, 2005
Last Updated: August 20, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Coronary Disease

Additional relevant MeSH terms:
Angina, Unstable
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Infarction
Myocardial Infarction
Angina Pectoris
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Coronary Disease
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on July 29, 2014