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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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

Summary results
Other publications