UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical outcome of prasugrel compared with clopidogrel
Title of the study (Brief title)	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	Takeshi Kimura
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Cardiovascular Medicine
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	Junichi Tazaki
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Cardiovascular Medicine
Address	54 Shogoin Kawaharacho Sakyo-ku Kyoto 606-8507 Japan
TEL	075-751-3188
Homepage URL
Email	jun1@kuhp.kyoto-u.ac.jp

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

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021004