UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031186 |
|---|---|
| Receipt number | R000035604 |
| Scientific Title | Comparison of MECHANISM of early and late vascular responses following treatment of ST-elevation Acute Myocardial Infarction with two different everolimus-eluting stents: Randomized controlled trial between biodegradable polymer and durable polymer stent |
| Date of disclosure of the study information | 2018/02/15 |
| Last modified on | 2023/08/24 11:54:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of MECHANISM of early and late vascular responses following treatment of ST-elevation Acute Myocardial Infarction with two different everolimus-eluting stents: Randomized controlled trial between biodegradable polymer and durable polymer stent
Acronym
MECHANISM-AMI-RCT
Scientific Title
Comparison of MECHANISM of early and late vascular responses following treatment of ST-elevation Acute Myocardial Infarction with two different everolimus-eluting stents: Randomized controlled trial between biodegradable polymer and durable polymer stent
Scientific Title:Acronym
MECHANISM-AMI-RCT
Region
| Japan |
Condition
Condition
ST-elevation acute myocardial infarction (STEMI)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare acute and late vascular responses to two different types of everolimus-etuting stents for the treatment of ST-elevation acute myocardial infarction evaluated by frequency domain optical coherence tomography
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
strut coverage rate at two weeks
Key secondary outcomes
thrombus, dissection, incomplete stent apposition, target lesion revascularization, etc
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
durable polymer-based everolimus-etulint stent
Interventions/Control_2
biodegradable polymer-based everolimus-etulint stent
Interventions/Control_3
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with
1)STEMI
2)Confirmation of coronary culprit lesion by angiography which need to be treated with drug-eluting stent
3)required cardiac catheterization after two weeks
Key exclusion criteria
Patients with
1)shock
2)left main disease
3)chronic kidney disease (serum Cr 2.0mg/dl)
4)cancer with life expectancy of less than 2 years
5)scheduled surgery within 3 months
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Morino |
Organization
Iwate Medical University
Division name
Division of Cardiology
Zip code
020-8505
Address
19-1, Uchimaru, Morioka
TEL
019-651-5111
ymorino@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Omiya |
Organization
Iwate Medical University
Division name
Division of Cardiology
Zip code
020-8505
Address
19-1, Uchimaru, Morioka
TEL
019-651-5111
Homepage URL
komoya@iwate-med.ac.jp
Sponsor or person
Institute
ARCHIMEDES Research Group
Institute
Department
Personal name
Funding Source
Organization
Boston Scientific
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Medical University Certified Review Board
Address
19-1, Uchimaru, Morioka
Tel
019-651-5111
hiroaki.kawamori@j.iwate-med.ac.jp
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
岩手医科大学病院 他 約20施設
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
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
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2018 | Year | 02 | Month | 07 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035604
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
