Expired Study
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Bridgewater, New Jersey


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.


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.


NCT ID:

NCT00123565


Primary Contact:

Study Director
ICD CSD
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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