Acute Myocardial InfarctionPhase 4NCT00423020
Anti-Restenosis After AMI by Erythropoietin
A Phase 4 study testing Erythropoietin in people with Acute Myocardial Infarction, run by Kyoto Prefectural University of Medicine at 1 site in Japan.
Trial summary
The EPOC-AMI study is to assess the safety and the efficacy of systemic administration of erythropoietin for inhibition of neointimal hyperplasia after stent implantation in the patients with acute myocardial infarction Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Erythropoietin
- How many people
- 72 participants
- Where
- 1 siteJapan
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute myocardial infarction within 12hrs of symptom onset.
- Succeeded reperfusion due to primary PCI accomplished bare metal stent
Who cannot join
- Patients with cardiogenic shock (e.g. systolic BP<80mmHg,use of catecholamine, use of IABP)
- Patients with anemia required transfusion
- Patients who are unwilling or unable to comply with the trial protocol
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
Takahisa Sawada, M.D., Ph.D., +81-75-251-5511, tsawada@koto.kpu-m.ac.jp
Hiroaki Matsubara, M.D., Ph.D., +81-75-251-5511, matsubah@koto.kpu-m.ac.jp
About this study
Official title: Erythropoietin Prevention Trial of Coronary Restenosis and Cardiac Remodeling After Acute Myocardial Infarction (EPOC-AMI)
The EPOC-AMI study is to assess the safety and the efficacy of systemic administration of erythropoietin for inhibition of neointimal hyperplasia after stent implantation in the patients with acute myocardial infarction
Read the detailed description
Stents coated with sirolimus or paclitaxel have been shown to significantly reduce restenosis in selected coronary lesions. However, the potential risk of late stent thrombosis forces prolonged treatment of dual anti-platelet regimen to all the patients after implantation of drug eluting stents. Patients with acute myocardial infarction may have uncertain clinical characteristics, such as occult bleeding focus or further need for surgical procedures. Thus, bare metal stent is considerably alternative for primary PCI after AMI and there remain an appreciable number of patients at risk for restenosis. Use of systemic pharmacological therapy to inhibit coronary stent restenosis of bare metal stent has been largely unsuccessful. We have reported that erythropoietin could enhance reendothelialization leading to inhibition of in-stent restenosis by directly protecting endothelial apoptosis and mobilizing endothelial progenitors. The EPOC-AMI study is designed to assess the safety and the efficacy of systemic administration of erythropoietin aiming inhibition of neointimal hyperplasia after stent implantation in the patients with acute myocardial infarction.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Erythropoietin
- Keywords
- Acute myocardial infarction, Restenosis, erythropoietin, EPOC-AMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent Neointimal volume
In-stent Late lumen loss
Semi-Quantitative evaluation of infarcted size of myocardium
Secondary outcomes (6)
left ventricular end diastolic volume
left ventricular end systolic volume
left ventricular ejection fraction
left ventricular wall motion index
binary restenosis
major adverse cardiac events (death,myocardial infarction, target lesion revascularization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 72 participants
Sponsor and investigators
- Lead sponsor
- Kyoto Prefectural University of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Hiroaki Matsubara, M.D., Ph.D., Study chair, Kyoto Prefectural University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423020
- Sponsor's protocol ID
- EPOC-AMI 2006
- Status last verified
- Jan 2007
- First submitted
- 16 Jan 2007
- Last updated
- 17 Jan 2007
- Results posted
- No
Publications
Urao N, Okigaki M, Yamada H, Aadachi Y, Matsuno K, Matsui A, Matsunaga S, Tateishi K, Nomura T, Takahashi T, Tatsumi T, Matsubara H. Erythropoietin-mobilized endothelial progenitors enhance reendothelialization via Akt-endothelial nitric oxide synthase activation and prevent neointimal hyperplasia. Circ Res. 2006 Jun 9;98(11):1405-13. doi: 10.1161/01.RES.0000224117.59417.f3. Epub 2006 Apr 27.
PubMed 16645141Taniguchi N, Nakamura T, Sawada T, Matsubara K, Furukawa K, Hadase M, Nakahara Y, Nakamura T, Matsubara H. Erythropoietin prevention trial of coronary restenosis and cardiac remodeling after ST-elevated acute myocardial infarction (EPOC-AMI): a pilot, randomized, placebo-controlled study. Circ J. 2010 Nov;74(11):2365-71. doi: 10.1253/circj.cj-10-0267. Epub 2010 Sep 8.
PubMed 20834185
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erythropoietin Prevention Trial of Coronary Restenosis and Cardiac Remodeling After Acute Myocardial Infarction (EPOC-AMI)
- ClinicalTrials.gov ID
- NCT00423020
- Acronym / sponsor ID
- EPOC-AMI 2006
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction, Restenosis, erythropoietin, EPOC-AMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants
- Lead sponsor
- Kyoto Prefectural University of MedicineUniversity, hospital or other
- First posted
- 17 Jan 2007 (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 EPOC-AMI study is to assess the safety and the efficacy of systemic administration of erythropoietin for inhibition of neointimal hyperplasia after stent implantation in the patients with acute myocardial infarction
Detailed description
Stents coated with sirolimus or paclitaxel have been shown to significantly reduce restenosis in selected coronary lesions. However, the potential risk of late stent thrombosis forces prolonged treatment of dual anti-platelet regimen to all the patients after implantation of drug eluting stents. Patients with acute myocardial infarction may have uncertain clinical characteristics, such as occult bleeding focus or further need for surgical procedures. Thus, bare metal stent is considerably alternative for primary PCI after AMI and there remain an appreciable number of patients at risk for restenosis. Use of systemic pharmacological therapy to inhibit coronary stent restenosis of bare metal stent has been largely unsuccessful. We have reported that erythropoietin could enhance reendothelialization leading to inhibition of in-stent restenosis by directly protecting endothelial apoptosis and mobilizing endothelial progenitors. The EPOC-AMI study is designed to assess the safety and the efficacy of systemic administration of erythropoietin aiming inhibition of neointimal hyperplasia after stent implantation in the patients with acute myocardial infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of acute myocardial infarction within 12hrs of symptom onset.
- Succeeded reperfusion due to primary PCI accomplished bare metal stent
Key exclusion criteria (3 listed)
- Patients with cardiogenic shock (e.g. systolic BP<80mmHg,use of catecholamine, use of IABP)
- Patients with anemia required transfusion
- Patients who are unwilling or unable to comply with the trial protocol
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 |
|---|---|---|
| Erythropoietin | Drug | – |
Primary outcome
In-stent Neointimal volume
In-stent Late lumen loss
Semi-Quantitative evaluation of infarcted size of myocardium
6 secondary outcomes
left ventricular end diastolic volume
left ventricular end systolic volume
left ventricular ejection fraction
left ventricular wall motion index
binary restenosis
major adverse cardiac events (death,myocardial infarction, target lesion revascularization)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2007.
- Background: PubMed 16645141Urao N, Okigaki M, Yamada H, Aadachi Y, Matsuno K, Matsui A, Matsunaga S, Tateishi K, Nomura T, Takahashi T, Tatsumi T, Matsubara H. Erythropoietin-mobilized endothelial progenitors enhance reendothelialization via Akt-endothelial nitric oxide synthase activation and prevent neointimal hyperplasia. Circ Res. 2006 Jun 9;98(11):1405-13. doi: 10.1161/01.RES.0000224117.59417.f3. Epub 2006 Apr 27.
- Derived from this study: PubMed 20834185Taniguchi N, Nakamura T, Sawada T, Matsubara K, Furukawa K, Hadase M, Nakahara Y, Nakamura T, Matsubara H. Erythropoietin prevention trial of coronary restenosis and cardiac remodeling after ST-elevated acute myocardial infarction (EPOC-AMI): a pilot, randomized, placebo-controlled study. Circ J. 2010 Nov;74(11):2365-71. doi: 10.1253/circj.cj-10-0267. Epub 2010 Sep 8.
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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.
Hiroaki Matsubara, M.D., Ph.D. study chair
Kyoto Prefectural University of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erythropoietin in people with Acute Myocardial Infarction, run by Kyoto Prefectural University of Medicine at 1 site in Japan.
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 3 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: status not confirmed, as of the sponsor's last update on 17 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Takahisa Sawada, M.D., Ph.D. (+81-75-251-5511, tsawada@koto.kpu-m.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent Neointimal volume. The study lists 3 primary outcomes in all. 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 NCT00423020, which also lists 2 linked publications.
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 17 Jan 2007.