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

Coronary Atherosclerosis Clinical Trial

— SHINE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123565
• Other study ID #: DRI5228
• Secondary ID: SR123781A
• Status: Completed
• Phase: Phase 2
• First received: July 22, 2005
• Last updated: August 20, 2008
• Start date: December 2004
• Est. completion date: May 2007

Study information

• Verified date: August 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1257
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Unstable
• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Drug:
• Hexadecasaccharide (SR123781A)

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis	Buenos Aires
Australia	Sanofi-Aventis	Macquarie Park
Belgium	Sanofi-Aventis	Diegem
Brazil	Sanofi-Aventis	Sao Paulo
Canada	Sanofi-Aventis	Laval	Quebec
Chile	Sanofi-Aventis	Providencia	Santiago
Czech Republic	Sanofi-Aventis	Praha
France	Sanofi-Aventis France	Paris
India	Sanofi-Aventis	India
Korea, Republic of	Sanofi-Aventis	Seoul
Mexico	Sanofi-Aventis	Mexico
Netherlands	Sanofi-Aventis	Gouda
Poland	Sanofi-Aventis	Warszawa
Portugal	Sanofi-Aventis	Porto Salvo
Russian Federation	Sanofi-Aventis	Moscow
Spain	Sanofi-aventis	Barcelona
Turkey	Sanofi-Aventis	Istanbul
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  Czech Republic,  France,  India,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Russian Federation,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group.

External Links

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