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

Primary Purpose

Coronary Atherosclerosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Hexadecasaccharide (SR123781A)
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Atherosclerosis focused on measuring Coronary Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis France
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-aventis
  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

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 Outcome Measures

Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group.

Full Information

First Posted
July 22, 2005
Last Updated
August 20, 2008
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00123565
Brief Title
Hexadecasaccharide (SR123781A) in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Atherosclerosis
Keywords
Coronary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1257 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Hexadecasaccharide (SR123781A)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
Country
United States
Facility Name
Sanofi-Aventis
City
Buenos Aires
ZIP/Postal Code
1642
Country
Argentina
Facility Name
Sanofi-Aventis
City
Macquarie Park
ZIP/Postal Code
NSW 2113
Country
Australia
Facility Name
Sanofi-Aventis
City
Diegem
ZIP/Postal Code
18 31
Country
Belgium
Facility Name
Sanofi-Aventis
City
Sao Paulo
ZIP/Postal Code
05677-000
Country
Brazil
Facility Name
Sanofi-Aventis
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7L 4A8
Country
Canada
Facility Name
Sanofi-Aventis
City
Providencia
State/Province
Santiago
Country
Chile
Facility Name
Sanofi-Aventis
City
Praha
ZIP/Postal Code
160 00
Country
Czech Republic
Facility Name
Sanofi-Aventis France
City
Paris
Country
France
Facility Name
Sanofi-Aventis
City
India
Country
India
Facility Name
Sanofi-Aventis
City
Seoul
Country
Korea, Republic of
Facility Name
Sanofi-Aventis
City
Mexico
ZIP/Postal Code
04000
Country
Mexico
Facility Name
Sanofi-Aventis
City
Gouda
ZIP/Postal Code
2803 PE
Country
Netherlands
Facility Name
Sanofi-Aventis
City
Warszawa
ZIP/Postal Code
02-672
Country
Poland
Facility Name
Sanofi-Aventis
City
Porto Salvo
ZIP/Postal Code
2740-244
Country
Portugal
Facility Name
Sanofi-Aventis
City
Moscow
ZIP/Postal Code
103045
Country
Russian Federation
Facility Name
Sanofi-aventis
City
Barcelona
ZIP/Postal Code
08019
Country
Spain
Facility Name
Sanofi-Aventis
City
Istanbul
ZIP/Postal Code
34 394
Country
Turkey

12. IPD Sharing Statement

Links:
URL
http://www.sanofi-aventis.com
Description
Related Info

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

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