Overview

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

Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
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.