UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016696 |
|---|---|
| Receipt number | R000018868 |
| Scientific Title | Effect of prasugrel on the angiographic parameters of myocardial perfusion |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2016/05/26 07:19:32 |
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Basic information
Public title
Effect of prasugrel on the angiographic parameters of myocardial perfusion
Acronym
Effect of prasugrel on the angiographic parameters of myocardial perfusion
Scientific Title
Effect of prasugrel on the angiographic parameters of myocardial perfusion
Scientific Title:Acronym
Effect of prasugrel on the angiographic parameters of myocardial perfusion
Region
| Japan |
Condition
Condition
ST elevation acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By comparing parasugrel with clopidogrel for the treatment of STEMI, we sought to investigate the early effect on the angiographic findings such as slow flow, distal embolization, crrected TIMI frame count, Blish score at the time of primary PCI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Incidence of distal embolization
Key secondary outcomes
Incidence of slow flow, no reflow phenomenon
Corrected TIMI frame count
Myocardial blush score
Maximum value of CK, CK-MB
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
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
| Medicine |
Interventions/Control_1
Prasugrel
Interventions/Control_2
Clopidogrel
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
STEMI (< 24 hours from the onset)
Primary PCI with informed consent
Key exclusion criteria
CPA or recovery from CPA
Cardiogenic Shock
Culprit lesion was bypass graft or left main trunk
No indication for PCI
Judgement for inappropriate patients by the doctors
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Kozuma |
Organization
Teikyo University Hospital
Division name
department of Cardiology
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1211
PXE00364@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ai Teramoto |
Organization
Teikyo University
Division name
Teikyo Academic Research Center
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
TEL
03-3964-1211
Homepage URL
ai.teramoto@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo Academic Research Center
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Company
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
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
帝京大学医学部附属病院循環器内科
三井記念病院循環器内科
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 31 | 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
The study was not initiated.
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
Terminated
Date of protocol fixation
| 2015 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 03 | Day |
Last modified on
| 2016 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018868
| Research Plan | |
|---|---|
| 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 |
