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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021380
Receipt No. R000024454
Scientific Title The effect of prasugrel on endothelial function in ischemic heart disease patients
Date of disclosure of the study information 2016/04/01
Last modified on 2018/03/10

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Basic information
Public title The effect of prasugrel on endothelial function in ischemic heart disease patients
Acronym The effect of prasugrel on endothelial function in ischemic heart disease patients
Scientific Title The effect of prasugrel on endothelial function in ischemic heart disease patients
Scientific Title:Acronym The effect of prasugrel on endothelial function in ischemic heart disease patients
Region
Japan

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

Objectives
Narrative objectives1 To investigate whether prasugrel improves endothelial function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reactive hyperemia index on 24 hours and 28 days after taking prasugrel compared with it on baseline
Key secondary outcomes P2Y12 reaction units on 23 hours and 28 days after taking prasugrel compared with it on baseline

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
80 years-old >=
Gender Male and Female
Key inclusion criteria The inclusion criteria included the following: patients undergoing elective PCI; patients keeping taking aspirin; patients agreeing with this study after informed consent.
Key exclusion criteria The exclusion criteria included the following: patients with unstable hemodynamics; patients underwent PCI or CABG within 4 weeks; patients in whom prasugrel is contraindicated; patients with severe hepatic dysfunction(liver cirrhosis, fulminant hepatitis, AST >100IU/L, ALT >100IU/L or Total bilirubin >3.0mg/dL); patients with severe renal dysfunction(eGFR <30mL/min); patients <50kg; patients with thorombocytepenia(platelet cell <100000/microL); patients with pregnancy or suspected pregnancy; patients administrated with anticoagulants(warfarin, dabigatran, rivaroxaban, apixaban or edoxaban); patients undergoing thrombolytic therapy; patinets administrated ticlopidine, cilostazol or clopidogrel; patients added or changed the drug for hypertension, dyslipidemia, diabetes or hyperuricemia within 2 weeks before agreement with this study; patients judged not eligible in this study.
Target sample size 30

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 department of cardiovascular medicine
Zip code
Address 1-8-1, inohana, Chuo-ku, Chiba city, Japan
TEL 043-222-7171
Email yoshio.kobayashi@wonder.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Tokimasa
Organization Chiba university graduate school of medicine
Division name department of cardiovascular medicine
Zip code
Address 1-8-1, inohana, Chuo-ku, Chiba city, Japan
TEL 043-222-7171
Homepage URL
Email YFD02270@nifty.com

Sponsor
Institute department of cadiovascular medicine, 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
2016 Year 04 Month 01 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
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2018 Year 01 Month 01 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information every patients who meet the selection criteria in them admitted to our facility from April 2016 to March 2017 are included.

Management information
Registered date
2016 Year 03 Month 07 Day
Last modified on
2018 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024454

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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