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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Coronary Atherosclerosis

Intervention / Treatment
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* Drug: Hexadecasaccharide (SR123781A)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hexadecasaccharide (SR123781A)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Disease