UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter observational study of real-world efficacy and safety of antithrombotic therapy underwent percutaneous coronary intervention (PCI)
Acronym	Multicenter observational study of efficacy and safety of antithrombotic therapy underwent percutaneous coronary intervention (PCI)
Scientific Title	Multicenter observational study of real-world efficacy and safety of antithrombotic therapy underwent percutaneous coronary intervention (PCI)
Scientific Title:Acronym	Multicenter observational study of efficacy and safety of antithrombotic therapy underwent percutaneous coronary intervention (PCI)
Region	Japan

Condition
Condition	Ischemic heart disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is aimed to investigate Post-PCI real-world antithrombotic period and prognosis by period.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Major adverse cardiac or cerebrovascuar events: cardiovascular death, non-fatal myocardial infarct, stent thrombosis, revascularization, stroke
Key secondary outcomes	Major bleeding event

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 those who have obtained the informed consent of the research subject
Key exclusion criteria	Patients with contraindications to antithrombotic therapy, Pregnant women, lactating women, women who may be pregnant
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Nobuhiro Middle name Last name Murata
Organization	Nihon University School of Medicine
Division name	Division of Cardiology, Department of Internal Medicine
Zip code	173-8610
Address	30-1, Oyaguchikami-cho, Itabashi-ku, Tokyo
TEL	03-3972-8111
Email	murata.nobuhiro@nihon-u.ac.jp

Public contact
Name of contact person	1st name Nobuhiro Middle name Last name Murata
Organization	Nihon University School of Medicine
Division name	Division of Cardiology, Department of Internal Medicine
Zip code	173-8610
Address	30-1, Oyaguchikami-cho, Itabashi-ku, Tokyo
TEL	03-3972-8111
Homepage URL
Email	murata.nobuhiro@nihon-u.ac.jp

Sponsor
Institute	Nihon University School of Medicine
Institute
Department

Funding Source
Organization	Nihon University School of Medicine
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	Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address	30-1, Oyaguchikami-cho, Itabashi-ku, Tokyo
Tel	03-3972-8111
Email	med.itabashi.chiken@nihon-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

Other administrative information
Date of disclosure of the study information	2020 Year 10 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	Open public recruiting
Date of protocol fixation	2020 Year 04 Month 01 Day
Date of IRB	2020 Year 03 Month 27 Day
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The administration period of antiplatelet drugs including DAPT in patients with ischemic heart disease emphasizes bleeding complications and tends to be significantly shortened even in Japanese guidelines. Against this background of the times, it is estimated that the administration period of antiplatelet drugs will be shortened rapidly even in clinical practice, and it can be said that the accumulation of evidence in clinical practice of antiplatelet drugs is an urgent issue.

Management information
Registered date	2020 Year 09 Month 19 Day
Last modified on	2020 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047773

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.