UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018133
Receipt number R000021004
Scientific Title Clinical outcome of prasugrel compared with clopidogrel
Date of disclosure of the study information 2015/07/01
Last modified on 2017/07/07 09:55:00

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Basic information

Public title

Clinical outcome of prasugrel compared with clopidogrel

Acronym

Clinical outcome of prasugrel

Scientific Title

Clinical outcome of prasugrel compared with clopidogrel

Scientific Title:Acronym

Clinical outcome of prasugrel

Region

Japan


Condition

Condition

Ischemic Heart Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is evaluate clinical outcome of prasugrel compared with clopidogrel for patients with ischemic heart disease in Japan.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

incidence of non-fatal myocardial infarction or stent thrombosis at 30 days

Key secondary outcomes

all cause death, ischemic stroke, hemorrhagic stroke, any bleeding events or rug allergy.


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with ischemic heart disease who underwent PCI with low-dose aspirin and thienopyridine in Kyoto university hospital between May 2013 and May 2015.

Key exclusion criteria

Contraindication of prasugrel or clopidogrel

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Kimura

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Cardiovascular Medicine

Zip code


Address

54 Shogoin Kawaharacho Sakyo-ku Kyoto 606-8507 Japan

TEL

075-751-4254

Email

taketaka@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junichi Tazaki

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Cardiovascular Medicine

Zip code


Address

54 Shogoin Kawaharacho Sakyo-ku Kyoto 606-8507 Japan

TEL

075-751-3188

Homepage URL


Email

jun1@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

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

京都大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2015 Year 07 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

Preinitiation

Date of protocol fixation

2015 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 06 Month 30 Day

Last modified on

2017 Year 07 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021004


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name