Clinical trial NCT00123565: Hexadecasaccharide (SR123781A) in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Atherosclerosis
Keywords: Coronary Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-07-25
Enrollment: 1257
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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 outcomes:
measure: Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group.
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis
city: Macquarie Park
country: Australia
facility: Sanofi-Aventis
city: Diegem
country: Belgium
facility: Sanofi-Aventis
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis
city: Laval
country: Canada
facility: Sanofi-Aventis
state: Quebec
city: Providencia
country: Chile
facility: Sanofi-Aventis
state: Santiago
city: Praha
country: Czech Republic
facility: Sanofi-Aventis
city: Paris
country: France
facility: Sanofi-Aventis France
city: India
country: India
facility: Sanofi-Aventis
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis
city: Mexico
country: Mexico
facility: Sanofi-Aventis
city: Gouda
country: Netherlands
facility: Sanofi-Aventis
city: Warszawa
country: Poland
facility: Sanofi-Aventis
city: Porto Salvo
country: Portugal
facility: Sanofi-Aventis
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis
city: Barcelona
country: Spain
facility: Sanofi-aventis
city: Istanbul
country: Turkey
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: