UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044193 |
|---|---|
| Receipt number | R000050464 |
| Scientific Title | Infarct size and long-term clinical outcomes of prasugrel vs. clopidogrel in patients with acute coronary syndrome undergoing coronary artery stenting: a prospective randomized study |
| Date of disclosure of the study information | 2021/05/13 |
| Last modified on | 2021/05/13 08:32:33 |
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Basic information
Public title
Infarct size and long-term clinical outcomes of prasugrel vs. clopidogrel in patients with acute coronary syndrome undergoing coronary artery stenting:
a prospective randomized study
Acronym
Study on the inhibitory effect of antiplatelet drugs on myocardial damage in acute coronary syndrome
Scientific Title
Infarct size and long-term clinical outcomes of prasugrel vs. clopidogrel in patients with acute coronary syndrome undergoing coronary artery stenting:
a prospective randomized study
Scientific Title:Acronym
Study on the inhibitory effect of antiplatelet drugs on myocardial damage in acute coronary syndrome
Region
| Japan |
Condition
Condition
acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The antiplatelet drug prasugrel inhibits platelet aggregation early after oral administration. This study examined whether prasugrel is effective in inhibiting infarct size and can reduce the incidence of major adverse cardiovascular events (MACE) in patients with acute coronary syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint was survival free of MACE.
Key secondary outcomes
The secondary endpoint was the evaluation of infarct size defined as the area under the curve of troponin I.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
prasugrel 20 mg before emergency PCI
Interventions/Control_2
clopidogrel 300 mg before emergency PCI
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases of stent implantation for acute coronary syndrome
Key exclusion criteria
Exclusion criteria were PCI without stenting, or final thrombolysis in myocardial infarction (TIMI) flow grade < 3.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yabe |
Organization
Toho University Omori Medical Center
Division name
Cardiology
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
0337624151
takayuki.yabe@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Yabe |
Organization
Toho University Omori Medical Center
Division name
Cardiology
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
0337624151
Homepage URL
takayuki.yabe@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University Omori Medical Center
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
Tel
0337624151
takayuki.yabe@med.toho-u.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
東邦大学医療センター大森病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 13 | 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
80
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
| 2014 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2021 | Year | 05 | Month | 12 | Day |
Last modified on
| 2021 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050464
| 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 |
