Coronary Atherosclerosis
Conditions
Keywords
Coronary Disease
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.
Interventions
DRUGHexadecasaccharide (SR123781A)
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group. | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, France, India, Mexico, Netherlands, Poland, Portugal, Russia, South Korea, Spain, Turkey (Türkiye), United States
Outcome results
None listed