Hexadecasaccharide (SR123781A) in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction (SHINE)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00123565
First received: July 22, 2005
Last updated: August 20, 2008
Last verified: August 2008
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123565
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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
| 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 May 16, 2013