UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021380
Receipt number 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 10:49:32

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

department of cadiovascular medicine, Chiba university graduate school of medicine

Institute

Department

Personal name



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

Value
https://center6.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