UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of prasugrel on endothelial function in ischemic heart disease patients
Title of the study (Brief title)	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	Yoshio Kobayashi
Organization	Chiba university graduate school of medicine
Division name	department of cardiovascular medicine
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	Satoshi Tokimasa
Organization	Chiba university graduate school of medicine
Division name	department of cardiovascular medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000024454