UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005721 |
|---|---|
| Receipt number | R000006762 |
| Scientific Title | Evaluation of the Prospective Observation of erythropoietin-administration for the treatment of Acute Myocardial Infarction-II |
| Date of disclosure of the study information | 2011/06/15 |
| Last modified on | 2015/06/09 08:23:20 |
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Basic information
Public title
Evaluation of the Prospective Observation of erythropoietin-administration for the treatment of Acute Myocardial Infarction-II
Acronym
EPO-AMI-II
Scientific Title
Evaluation of the Prospective Observation of erythropoietin-administration for the treatment of Acute Myocardial Infarction-II
Scientific Title:Acronym
EPO-AMI-II
Region
| Japan |
Condition
Condition
Acute Myocardial Infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the administration of epoetin-beta (6000unit or 12000unit) to patients with AMI who are underwent successful PCI within 12 hours after onset is able to improve reperfusion injury in dose-dependent manner in randomized, placebo-controlled, double-blind trial, and to estimate appropriate dose for clinical use.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement of left ventricular ejection fraction at the chronic phase (the mean of differences between LVEF value at 4-7 days and that at 6 months after administration)
Key secondary outcomes
[Efficacy]
1.Indexes of cardiac function 6 months after administration of epoetin-beta, which are calculated with cardiac scintigraphy. (LVEDV, LVESV, LVEDVI, LVESVI, regional wall motion score, %uptake at resting), and defect size (%Defect Size: SRS (Summed rest Score), SDS (Summed difference Score))
2.Survival ratio
3.Cardiac event ratio (Cardiac death, stroke, nonlethal myocardial infarction, admission due to worsening of heart failure, revasculization, onset of heart failure symptoms)
4.NT-ProBNP 6 months after administration.
[safety]
1.adverse events
2.laboratory test data
3.vital signs (blood pressure, pulse rate)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Epoetin-beta(12,000 unit) treatment group
Interventions/Control_2
Epoetin-beta (6,000 unit) treatment group
Interventions/Control_3
Placebo treatment group
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with first-time myocardial infarction
2) Patients with ST-elevation acute myocardial infarction (AMI) who have successful reperfusion by PCI within 12 hours after the symptom onset.
3) Patients whose ejection fraction at enrollment is <50% on UCG or LVG.
4) Age: over 20 years old, under 80 years old
5) Patients who agreed with participation to the trial in writing.
Key exclusion criteria
1) Patients with significant stenotic lesions which require revascularization.
2) Patients who resulted in obviously impaired reperfusion.
3) Patients with Killip class III or IV, or cardiogenic shock at admission.
4) Patients with advanced renal or hepatic dysfunction (Cre more than 2mg/dl, or T-Bil more than 3mg/dl)
5) Patients with blood pressure more than 140/90mmHg after PCI.
6) Hematocrit more than 54% after PCI.
7) Patients who exhibit atrial fibrillation after PCI.
8) Patients who has been diagnosed with malignant hypertension.
9) Patients who has previously received treatment with rhEPO.
10) Patients who received a blood transfusion in the last three months.
11) Patients who is or has been diagnosed with cancer in the past 5 years.
12) Patients who are complicated with severe infection such as pneumonia or sepsis.
13) Patients who are contraindicated to aspirin or thienopyridine derivatives.
14)Women who is pregnant, breastfeeding, or has a possibility for pregnancy.
15) Patients whom researchers judged that they are not appropriate to participate this trial.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | (1) Yoshifusa Aizawa, (2) Issei Komuro, (3) Tetsuo Minamino |
Organization
(1) TACHIKAWA Medical Center
(2) Tokyo University Graduate School of Medicine
(3)Osaka University Graduate School of Medicine
Division name
(1) Division of Cardiology, (2) Department of Cardiovascular Medicine, (3) Department of Cardiovascular Medicine
Zip code
Address
(1) 3-2-1 Kandacho, Nagaoka, Niigata, 940-8621, Japan, (2) 7-3-1 Hongo, Bunkyo, Tokyo, 113-8655, Japan, (3) 2-2 Yamadaoka, Suita, 565-0871, Japan
TEL
06-6879-3635
epoami2office@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuo Minamino |
Organization
Cardioprotection Workshop
Division name
Research Office of EPO-AMI-II
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3635
Homepage URL
epoami2office@umin.ac.jp
Sponsor or person
Institute
Cardioprotection Workshop
Institute
Department
Personal name
Funding Source
Organization
The Japanese Circulation Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Minstry of Health, Labour and Welfare
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
http://www.epoami2.com/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 04 | Day |
Last modified on
| 2015 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006762
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
