Coronary DiseasePhase 2SEPIA-ACS1NCT00317395
Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome
A Phase 2 study testing Otamixaban (XRP0673), unfractionated heparin and eptifibatide in people with Coronary Disease, run by Sanofi at 36 sites in 36 countries.
Trial summary
Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Otamixaban (XRP0673), unfractionated heparin and eptifibatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,241 participants
- Where
- 36 sitesin 36 countries
- Study dates
- Jun 2006to Mar 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic discomfort at rest ≥ 10 minutes within 24 hours of randomization
- Electrocardiogram (ECG) criteria for non-ST elevation ACS or cardiac enzyme elevation (> upper limit of normal [ULN])
- No ST elevation Myocardial Infarction (STEMI)
- Planned coronary angiography followed when indicated by a Percutaneous Coronary Intervention (PCI) on Day 1 to Day 3
Who cannot join
- Inability to undergo coronary angiography or PCI by Day 3
- Prior PCI within 30 days
- Acute STEMI
- Cardiogenic shock
- Anticoagulant treatment for > 24 hours prior to randomization
- Prior treatment with fondaparinux since ACS onset
- Requirement for oral anticoagulant (OAC) prior to Day 30
- Creatinine clearance < 30 ml/min
Trial locations and contacts
36 sites in 36 countries.
36 sites in 36 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Randomized, Double-blind, Triple-dummy, Dose-ranging Study, Including an Active Control of Unfractionated Heparin and Eptifibatide, to Evaluate the Clinical Efficacy and Safety of Otamixaban, in Patients With Non-ST Elevation Acute Coronary Syndrome and Planned Early Invasive Strategy
Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy.
Secondary objectives: To evaluate safety and assess pharmacokinetics (PK) and pharmacodynamics (PD).
- Conditions
- Coronary Disease
- Being tested
- Otamixaban (XRP0673), unfractionated heparin, eptifibatide
- Keywords
- Non ST elevation Acute Coronary Syndrome, Early invasive strategy, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otamixaban (XRP0673)Drug
intravenous administration
unfractionated heparinDrug
intravenous administration
eptifibatideDrug
intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Otamixaban Dose 1 | Experimental | dosage regimen 1 Receives: Drug: Otamixaban (XRP0673) |
| Otamixaban Dose 2 | Experimental | dosage regimen 2 Receives: Drug: Otamixaban (XRP0673) |
| Otamixaban Dose 3 | Experimental | dosage regimen 3 Receives: Drug: Otamixaban (XRP0673) |
| Otamixaban Dose 4 | Experimental | dosage regimen 4 Receives: Drug: Otamixaban (XRP0673) |
| Otamixaban Dose 5 | Experimental | dosage regimen 5 Receives: Drug: Otamixaban (XRP0673) |
| UFH/Eptifibatide | Active comparator | Not described Receives: Drug: unfractionated heparin; Drug: eptifibatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor
Measured: within 7 days following randomization
Secondary outcomes (4)
Net clinical benefit: composite of the primary efficacy end point and Thrombolysis in Myocardial Infarction (TIMI) significant bleeding
Measured: within 7 days and 30 days following randomization
Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor
Measured: within 30 days, 90 days and 180 days following randomization
Incidence of TIMI significant bleeding
Measured: within 7 days following randomization
Incidence of all bleedings
Measured: within 7 days and 30 days following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2006 (estimated)
- Study startJun 2006
- Primary completionOct 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 3,241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317395
- Sponsor's protocol ID
- DRI6624
- Other IDs
- XRP0673A/2003, 2006-000506-22
- Acronym
- SEPIA-ACS1
- Status last verified
- Nov 2014
- First submitted
- 21 Apr 2006
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sabatine MS, Antman EM, Widimsky P, Ebrahim IO, Kiss RG, Saaiman A, Polasek R, Contant CF, McCabe CH, Braunwald E. Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes (SEPIA-ACS1 TIMI 42): a randomised, double-blind, active-controlled, phase 2 trial. Lancet. 2009 Sep 5;374(9692):787-95. doi: 10.1016/S0140-6736(09)61454-9. Epub 2009 Aug 28.
PubMed 19717184
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Triple-dummy, Dose-ranging Study, Including an Active Control of Unfractionated Heparin and Eptifibatide, to Evaluate the Clinical Efficacy and Safety of Otamixaban, in Patients With Non-ST Elevation Acute Coronary Syndrome and Planned Early Invasive Strategy
- ClinicalTrials.gov ID
- NCT00317395
- Acronym / sponsor ID
- SEPIA-ACS1 / DRI6624
- Conditions
- Coronary Disease
- Keywords
- Non ST elevation Acute Coronary Syndrome, Early invasive strategy, Percutaneous Coronary Intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,241 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 Apr 2006 (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.
Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy.
Secondary objectives: To evaluate safety and assess pharmacokinetics (PK) and pharmacodynamics (PD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Otamixaban Dose 1 | Experimental | Drug: Otamixaban (XRP0673)dosage regimen 1 |
| Otamixaban Dose 2 | Experimental | Drug: Otamixaban (XRP0673)dosage regimen 2 |
| Otamixaban Dose 3 | Experimental | Drug: Otamixaban (XRP0673)dosage regimen 3 |
| Otamixaban Dose 4 | Experimental | Drug: Otamixaban (XRP0673)dosage regimen 4 |
| Otamixaban Dose 5 | Experimental | Drug: Otamixaban (XRP0673)dosage regimen 5 |
| UFH/Eptifibatide | Active comparator | Drug: unfractionated heparin, Drug: eptifibatide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic discomfort at rest ≥ 10 minutes within 24 hours of randomization
- Electrocardiogram (ECG) criteria for non-ST elevation ACS or cardiac enzyme elevation (> upper limit of normal [ULN])
- No ST elevation Myocardial Infarction (STEMI)
- Planned coronary angiography followed when indicated by a Percutaneous Coronary Intervention (PCI) on Day 1 to Day 3
Key exclusion criteria (8 listed)
- Inability to undergo coronary angiography or PCI by Day 3
- Prior PCI within 30 days
- Acute STEMI
- Cardiogenic shock
- Anticoagulant treatment for > 24 hours prior to randomization
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 |
|---|---|---|
| Otamixaban (XRP0673)intravenous administration | Drug | Otamixaban Dose 1, Otamixaban Dose 2, Otamixaban Dose 3, Otamixaban Dose 4, Otamixaban Dose 5 |
| unfractionated heparinintravenous administration | Drug | UFH/Eptifibatide |
| eptifibatideintravenous administration | Drug | UFH/Eptifibatide |
Primary outcome
Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor
Time frame: within 7 days following randomization
4 secondary outcomes
Net clinical benefit: composite of the primary efficacy end point and Thrombolysis in Myocardial Infarction (TIMI) significant bleeding
Time frame: within 7 days and 30 days following randomization
Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor
Time frame: within 30 days, 90 days and 180 days following randomization
Incidence of TIMI significant bleeding
Time frame: within 7 days following randomization
Incidence of all bleedings
Time frame: within 7 days and 30 days following randomization
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 3 Dec 2014.
- Results publication: PubMed 19717184Sabatine MS, Antman EM, Widimsky P, Ebrahim IO, Kiss RG, Saaiman A, Polasek R, Contant CF, McCabe CH, Braunwald E. Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes (SEPIA-ACS1 TIMI 42): a randomised, double-blind, active-controlled, phase 2 trial. Lancet. 2009 Sep 5;374(9692):787-95. doi: 10.1016/S0140-6736(09)61454-9. Epub 2009 Aug 28.
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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
36 sites in 36 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Otamixaban (XRP0673), unfractionated heparin and eptifibatide in people with Coronary Disease, run by Sanofi at 36 sites in 36 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 4 inclusion and 8 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Argentina, Austria, Brazil, Bulgaria and 31 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?
Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor (time frame: 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?
On the ClinicalTrials.gov record for NCT00317395, which also lists 1 linked publication.
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 3 Dec 2014.