Clinical Trials Directory

Trials / Completed

CompletedNCT00123565

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

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)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
1,257 (actual)
Sponsor
Sanofi · Industry
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGHexadecasaccharide (SR123781A)

Timeline

Start date
2004-12-01
Primary completion
2007-05-01
Completion
2007-05-01
First posted
2005-07-25
Last updated
2008-08-21

Locations

18 sites across 18 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, France, India, Mexico, Netherlands, Poland, Portugal, Russia, South Korea, Spain, Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT00123565. Inclusion in this directory is not an endorsement.