UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of prasugrel on the angiographic parameters of myocardial perfusion
Title of the study (Brief title)	Effect of prasugrel on the angiographic parameters of myocardial perfusion
Region	Japan

Condition
Condition	ST elevation acute myocardial infarction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	By comparing parasugrel with clopidogrel for the treatment of STEMI, we sought to investigate the early effect on the angiographic findings such as slow flow, distal embolization, crrected TIMI frame count, Blish score at the time of primary PCI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Incidence of distal embolization
Key secondary outcomes	Incidence of slow flow, no reflow phenomenon Corrected TIMI frame count Myocardial blush score Maximum value of CK, CK-MB

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Prasugrel
Interventions/Control_2	Clopidogrel
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	STEMI (< 24 hours from the onset) Primary PCI with informed consent
Key exclusion criteria	CPA or recovery from CPA Cardiogenic Shock Culprit lesion was bypass graft or left main trunk No indication for PCI Judgement for inappropriate patients by the doctors
Target sample size	50

Research contact person
Name of lead principal investigator	Ken Kozuma
Organization	Teikyo University Hospital
Division name	department of Cardiology
Address	2-11-1 Kaga, Itabashi-ku, Tokyo
TEL	03-3964-1211
Email	PXE00364@nifty.com

Public contact
Name of contact person	Ai Teramoto
Organization	Teikyo University
Division name	Teikyo Academic Research Center
Address	2-11-1 Kaga, Itabashi-ku, Tokyo
TEL	03-3964-1211
Homepage URL
Email	ai.teramoto@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo Academic Research Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Daiichi Sankyo Company
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	帝京大学医学部附属病院循環器内科 三井記念病院循環器内科

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 03 Month 03 Day
Anticipated trial start date	2015 Year 03 Month 31 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 05 Month 31 Day
Date trial data considered complete	2016 Year 06 Month 30 Day
Date analysis concluded	2016 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The study was not initiated.
Other related information

Management information
Registered date	2015 Year 03 Month 03 Day
Last modified on	2016 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018868