Myocardial InfarctionPhase 2EPOMINCT00648089
EPOMI Study: ErythroPOietin in Myocardial Infarction
A Phase 2 study testing EPO in people with Myocardial Infarction, run by University Hospital, Angers at 2 sites in France.
Trial summary
EPOMI is a randomized, open-label, parallel phase II clinical study that will evaluate the effects of a single erythropoietin administration on infarct size and cardiac remodeling in patients with acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- EPO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2008to Dec 2010
- 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
- ST-Segment elevation myocardial infarction <6h
- Infarct related artery : proximal circumflex artery , proximal and mid left anterior descending artery, 1st segment of the right coronary artery
- TIMI 0 or 1 before angioplasty
- Successful PCI defined by residual stenosis < 50% and TIMI 2 or 3 flow grade
- Body weight : [50-110] kg
- Informed, written consent
Who cannot join
- Age < 18
- Pregnant, or parturient or breast-feeding women;
- Sexually active women without efficient contraception;
- Inability to fully cooperate with the study protocol
- Pre-treatment with fibrinolysis ;
- Previous Q-wave myocardial infarction or previous aorto-coronary bypass;
Show all 17Show fewer
- History of deep vein thrombosis or pulmonary embolism;
- Contraindication to aspirin or clopidogrel ;
- Cardiogenic shock ;
- Cardiac resuscitated before angioplasty ;
- Past or active erythropoietin therapy;
- Contraindications to erythropoietin therapy: uncontrolled hypertension, known hypersensitivity to benzoic acid, chronic liver insufficiency, hemoglobin> 16g / l, thrombocytosis, refractory anemia with excess of blasts;
- Renal insufficiency (creatinine clearance <30ml/mn.);
- Active Malignancies
- Any contraindications to magnetic resonance imaging: pacemaker and automatic cardiac defibrillator, hearing aid, neurostimulator, infusion pump etc metallic splinters in the eye, ferromagnetic haemostatic clips in the central nervous system cochlear implants, claustrophobia;
- Allergy to gadolinium ;
- Patient refusal / patient not having provided written informed consent.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: ErythroPOietin in Myocardial Infarction
EPOMI is a randomized, open-label, parallel phase II clinical study that will evaluate the effects of a single erythropoietin administration on infarct size and cardiac remodeling in patients with acute myocardial infarction. Eligible patients will be randomly assigned to receive conventional therapy and single infusion of 1000U/kg of epoetin beta or conventional therapy alone. Infarct size and cardiac remodeling parameters will be assessed by cardiac magnetic resonance imaging (MRI) within 3-7 days of the randomization and repeated 3 months later.
- Conditions
- Myocardial Infarction
- Being tested
- EPO
- Keywords
- Acute ST Elevation Myocardial Infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPODrug
Single Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: EPO |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in infarct size as assessed by magnetic resonance imaging 3 months after administration of study medication
Measured: within 3-7 days of administration of study medication
Secondary outcomes (3)
End-systolic volume, end-diastolic volume, ejection fraction
Measured: within 3-7 days of administration of study medication, and 3 months later
Changes in hemoglobin, platelets, reticulocytes blood count
Measured: during the first 10 days following study medication administration
Occurrence of major cardiac event or venous thrombotic events
Measured: within 12 months following administration of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2010
- Study completionDec 2010
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 Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Fédération Française de Cardiologie, Société Française de Cardiologie
- Investigators
- Fabrice PRUNIER, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648089
- Sponsor's protocol ID
- PHRC 2007-03
- Acronym
- EPOMI
- Status last verified
- Jan 2011
- First submitted
- 27 Mar 2008
- Last updated
- 31 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prunier F, Biere L, Gilard M, Boschat J, Mouquet F, Bauchart JJ, Charbonnier B, Genee O, Guerin P, Warin-Fresse K, Durand E, Lafont A, Christiaens L, Abi-Khalil W, Delepine S, Benard T, Furber A. Single high-dose erythropoietin administration immediately after reperfusion in patients with ST-segment elevation myocardial infarction: results of the erythropoietin in myocardial infarction trial. Am Heart J. 2012 Feb;163(2):200-7.e1. doi: 10.1016/j.ahj.2011.11.005.
PubMed 22305837
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ErythroPOietin in Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00648089
- Acronym / sponsor ID
- EPOMI / PHRC 2007-03
- Conditions
- Myocardial Infarction
- Keywords
- Acute ST Elevation Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Fédération Française de Cardiologie, Société Française de Cardiologie
- Study start
- Apr 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Apr 2008 (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.
EPOMI is a randomized, open-label, parallel phase II clinical study that will evaluate the effects of a single erythropoietin administration on infarct size and cardiac remodeling in patients with acute myocardial infarction. Eligible patients will be randomly assigned to receive conventional therapy and single infusion of 1000U/kg of epoetin beta or conventional therapy alone. Infarct size and cardiac remodeling parameters will be assessed by cardiac magnetic resonance imaging (MRI) within 3-7 days of the randomization and repeated 3 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: EPO |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ST-Segment elevation myocardial infarction <6h
- Infarct related artery : proximal circumflex artery , proximal and mid left anterior descending artery, 1st segment of the right coronary artery
- TIMI 0 or 1 before angioplasty
- Successful PCI defined by residual stenosis < 50% and TIMI 2 or 3 flow grade
- Body weight : [50-110] kg
Key exclusion criteria (17 listed)
- Age < 18
- Pregnant, or parturient or breast-feeding women;
- Sexually active women without efficient contraception;
- Inability to fully cooperate with the study protocol
- Pre-treatment with fibrinolysis ;
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 |
|---|---|---|
| EPOSingle Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI | Drug | 1 |
Primary outcome
Changes in infarct size as assessed by magnetic resonance imaging 3 months after administration of study medication
Time frame: within 3-7 days of administration of study medication
3 secondary outcomes
End-systolic volume, end-diastolic volume, ejection fraction
Time frame: within 3-7 days of administration of study medication, and 3 months later
Changes in hemoglobin, platelets, reticulocytes blood count
Time frame: during the first 10 days following study medication administration
Occurrence of major cardiac event or venous thrombotic events
Time frame: within 12 months following administration of study medication
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 31 Jan 2011.
- Derived from this study: PubMed 22305837Prunier F, Biere L, Gilard M, Boschat J, Mouquet F, Bauchart JJ, Charbonnier B, Genee O, Guerin P, Warin-Fresse K, Durand E, Lafont A, Christiaens L, Abi-Khalil W, Delepine S, Benard T, Furber A. Single high-dose erythropoietin administration immediately after reperfusion in patients with ST-segment elevation myocardial infarction: results of the erythropoietin in myocardial infarction trial. Am Heart J. 2012 Feb;163(2):200-7.e1. doi: 10.1016/j.ahj.2011.11.005.
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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.
Fabrice PRUNIER, MD, PhD principal investigator
University Hospital, Angers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EPO in people with Myocardial Infarction, run by University Hospital, Angers at 2 sites in France.
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 6 inclusion and 17 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 31 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Changes in infarct size as assessed by magnetic resonance imaging 3 months after administration of study medication (time frame: within 3-7 days of administration of study medication). 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 NCT00648089, 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 31 Jan 2011.