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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00123565




Registration number
NCT00123565
Ethics application status
Date submitted
22/07/2005
Date registered
25/07/2005
Date last updated
21/08/2008

Titles & IDs
Public title
Hexadecasaccharide (SR123781A) in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction
Scientific 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)
Secondary ID [1] 0 0
SR123781A
Secondary ID [2] 0 0
DRI5228
Universal Trial Number (UTN)
Trial acronym
SHINE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Atherosclerosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Hexadecasaccharide (SR123781A)

Treatment: Drugs: Hexadecasaccharide (SR123781A)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group.
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2007
Sample size
Target
Accrual to date
Final
1257
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis - Macquarie Park
Recruitment postcode(s) [1] 0 0
NSW 2113 - Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Belgium
State/province [3] 0 0
Diegem
Country [4] 0 0
Brazil
State/province [4] 0 0
Sao Paulo
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Chile
State/province [6] 0 0
Santiago
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Praha
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
India
State/province [9] 0 0
India
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
Mexico
State/province [11] 0 0
Mexico
Country [12] 0 0
Netherlands
State/province [12] 0 0
Gouda
Country [13] 0 0
Poland
State/province [13] 0 0
Warszawa
Country [14] 0 0
Portugal
State/province [14] 0 0
Porto Salvo
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Moscow
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Turkey
State/province [17] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00123565
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries