UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and Safety of Low Dose Prasugrel in Japanese Acute Coronary Syndrome Patients: A Single-center Prospective Clinical Trial
Title of the study (Brief title)	Efficacy and Safety of Low Dose Prasugrel
Region	Japan

Condition
Condition	Acute Coronary Syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aimed to assess the efficacy and safety of maintainance of low dose prasugrel (2.5mg/day) in Japanese acute coronary syndrome patients, especially with bleeding tendency.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	MACCE(major adverse cardiovascular and cerebral event) until coronray angiography examination at eight months after index procedure: all-cause death, cardiac death, non-fatal myocardial infarction, non-fatal cerebrovascular events, any revascularization, target lesion revascularization, stent thrombosis
Key secondary outcomes	in-hospital and out-hospital bleeding (until coronray angiography examination at eight months after index procedure), major bleeding not related to coronary artery bypass graft (BARC classification type 3 or greater), minor bleeding (BARC classification type 2 or less), cessation of antiplatelet drug according to bleeding events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In patients after percutaneous coronary intervention with low body weight (body weight 50 kg or under), older age (75 years old or over), or renal insufficiency (eGFR 30 ml/min/1.73m2 or under), the low-dose prasugrel (2.5 mg/day) is maintained for eight months.
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	(1) adult patients receiving percutaneous coronary intervention with acute coronary syndrome (2) patients with low body weight (body weight 50 kg or under), elderly (75 years old or over), or renal insufficiency (eGFR 30 ml/min/1.73m2 or under)
Key exclusion criteria	(1) bleeding patients (hemophilia, cerebral bleeding, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, or vitreous hemorrhage) (2) hypersensitive patients for prasugrel in past times (Relative exclusion criteria) (1) patients with cerebral bleeding or critical bleeding (BARC classification 3 or greater) (2) patients with past history of cerebral infarction or transient ischemic attack (3) patients with anticoagulant therapy or scheduled for anticoagulant therapy (4) patients with thienopyridine therapy already
Target sample size	250

Research contact person
Name of lead principal investigator	Kazushige Kadota
Organization	Kurashiki Central Hospital
Division name	Department of Cardiology
Address	1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL	086-422-0210
Email	k-kadota@lapis.plala.or.jp

Public contact
Name of contact person	Masanobu Ohya
Organization	Kurashiki Central Hospital
Division name	Department of Cardiology
Address	1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL	086-422-0210
Homepage URL
Email	mo13590@kchnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	倉敷中央病院(岡山県)

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 26 Day
Anticipated trial start date	2014 Year 08 Month 28 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 30 Day
Last modified on	2018 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022033