Coronary AtherosclerosisPhase 2SHINENCT00123565
Hexadecasaccharide (SR123781A) in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction
A Phase 2 study testing Hexadecasaccharide (SR123781A) in people with Coronary Atherosclerosis, run by Sanofi at 18 sites in 18 countries.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Atherosclerosis
- What is being tested?
- Hexadecasaccharide (SR123781A)
- How many people
- 1,257 participants
- Where
- 18 sitesin 18 countries
- Study dates
- Dec 2004to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
18 sites in 18 countries.
18 sites in 18 countries
About this study
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)
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.
- Conditions
- Coronary Atherosclerosis
- Being tested
- Hexadecasaccharide (SR123781A)
- Keywords
- Coronary Disease
- Medical subject headings
- Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hexadecasaccharide (SR123781A)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (1)
Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2005 (estimated)
- Study startDec 2004
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AtherosclerosisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123565
- Sponsor's protocol ID
- DRI5228
- Other IDs
- SR123781A
- Acronym
- SHINE
- Status last verified
- Aug 2008
- First submitted
- 22 Jul 2005
- Last updated
- 21 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00123565
- Acronym / sponsor ID
- SHINE / DRI5228
- Conditions
- Coronary Atherosclerosis
- Keywords
- Coronary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,257 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 25 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hexadecasaccharide (SR123781A) | Drug | – |
Primary outcome
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.
1 secondary outcome
Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2008.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
18 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hexadecasaccharide (SR123781A) in people with Coronary Atherosclerosis, run by Sanofi at 18 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Argentina, Australia, Belgium, Brazil and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2008.