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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029481
Receipt No. R000033664
Scientific Title Multicenter research of comparison between prasugrel and clopidogrel in ischemic heart disease undergoing PCI
Date of disclosure of the study information 2017/10/10
Last modified on 2017/10/10

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Basic information
Public title Multicenter research of comparison between prasugrel and clopidogrel in ischemic heart disease undergoing PCI
Acronym comparison between prasugrel and clopidogrel
Scientific Title Multicenter research of comparison between prasugrel and clopidogrel in ischemic heart disease undergoing PCI
Scientific Title:Acronym comparison between prasugrel and clopidogrel
Region
Japan

Condition
Condition Ischemic heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Lower loading and maintenance doses of prasugrel have been established for Japanese patients (loading dose [LD]/maintenance dose [MD], 20/3.75mg) compared to those for Western patients (LD/MD, 60/10mg), considering the higher average age, lower body weight, and increased bleeding risk with other thrombotic agents in Japanese patients.
Although it has been reported that even low-dose prasugrel achieves stronger antiplatelet effect and fewer cardiovascular events compared to standard-dose clopidogrel in Japanese patients, there are limited data comparing the safety between low-dose prasugrel and standard-dose clopidogrel.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Major adverse cardiovascular events (MACE) were defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal ischemic stroke.
Adverse events were defined as a composite of bleeding, hepatopathy, leukopenia, thrombopenia, exanthema, and MACE.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Ischemic heart disease patinets undergoing PCI between May 2014 to May 2016 who started newly prasugrel or clopidogrel and kept dual anti-platelet therapy.
Key exclusion criteria Prescribed P2Y12 inhibitors before first PCI more than a month ago
Switching P2Y12 inhibitors within 2weeks without comprehensible reasons
Self-interruption of P2Y12 inhibitors
Follow-up periods within 2 weeks
Not documented doses of P2Y12 inhibitors
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Kobayashi
Organization Chiba University Graduate school of medicine
Division name Cardiovascular medicine
Zip code
Address 1-8-1, Inohana, Chuo ward, Chiba city, Chiba pref
TEL 043-222-7171
Email uiryosuke@msn.com

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Tokimasa
Organization Chiba University Graduate school of medicine
Division name Cardiovascular medicine
Zip code
Address 1-8-1, Inohana, Chuo ward, Chiba city, Chiba pref
TEL 043-222-7171
Homepage URL
Email YFD02270@nifty.com

Sponsor
Institute Chiba University Graduate school of medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 10 Month 10 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 No longer recruiting
Date of protocol fixation
2017 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 10 Month 10 Day
Last modified on
2017 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033664

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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