UMIN-CTR Clinical Trial

Basic information
Public title	Infarct size and long-term clinical outcomes of prasugrel vs. clopidogrel in patients with acute coronary syndrome undergoing coronary artery stenting: a prospective randomized study
Acronym	Study on the inhibitory effect of antiplatelet drugs on myocardial damage in acute coronary syndrome
Scientific Title	Infarct size and long-term clinical outcomes of prasugrel vs. clopidogrel in patients with acute coronary syndrome undergoing coronary artery stenting: a prospective randomized study
Scientific Title:Acronym	Study on the inhibitory effect of antiplatelet drugs on myocardial damage in acute coronary syndrome
Region	Japan

Condition
Condition	acute coronary syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The antiplatelet drug prasugrel inhibits platelet aggregation early after oral administration. This study examined whether prasugrel is effective in inhibiting infarct size and can reduce the incidence of major adverse cardiovascular events (MACE) in patients with acute coronary syndrome.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary endpoint was survival free of MACE.
Key secondary outcomes	The secondary endpoint was the evaluation of infarct size defined as the area under the curve of troponin I.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	prasugrel 20 mg before emergency PCI
Interventions/Control_2	clopidogrel 300 mg before emergency PCI
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases of stent implantation for acute coronary syndrome
Key exclusion criteria	Exclusion criteria were PCI without stenting, or final thrombolysis in myocardial infarction (TIMI) flow grade < 3.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Takayuki Middle name Last name Yabe
Organization	Toho University Omori Medical Center
Division name	Cardiology
Zip code	143-8541
Address	6-11-1 Omorinishi, Ota-ku, Tokyo
TEL	0337624151
Email	takayuki.yabe@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Takayuki Middle name Last name Yabe
Organization	Toho University Omori Medical Center
Division name	Cardiology
Zip code	143-8541
Address	6-11-1 Omorinishi, Ota-ku, Tokyo
TEL	0337624151
Homepage URL
Email	takayuki.yabe@med.toho-u.ac.jp

Sponsor
Institute	Toho University Omori Medical Center
Institute
Department

Funding Source
Organization	Non
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Toho University Omori Medical Center
Address	6-11-1 Omorinishi, Ota-ku, Tokyo
Tel	0337624151
Email	takayuki.yabe@med.toho-u.ac.jp

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	東邦大学医療センター大森病院(東京都)

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 13 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	80
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	2014 Year 08 Month 08 Day
Date of IRB	2014 Year 08 Month 08 Day
Anticipated trial start date	2014 Year 08 Month 08 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 12 Day
Last modified on	2021 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050464