Hexadecasaccharide (SR123781A) in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction (SHINE)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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)|
- 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.
- Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group.
|Study Start Date:||December 2004|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123565
Show 18 Study Locations
|Study Director:||ICD CSD||Sanofi|