UMIN-CTR Clinical Trial

Basic information
Public title	Coronary intervention and optimal AntiPlatelet Therapy-Optical coherence tomography study-
Acronym	CAPTO study
Scientific Title	Coronary intervention and optimal AntiPlatelet Therapy-Optical coherence tomography study-
Scientific Title:Acronym	CAPTO study
Region	Japan

Condition
Condition	coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To validate the clopidogrel single use after dual antiplatelet therapy in patients implanted drug eluting stent, using optical coherence tomography
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of OCT parameter after switch to single antiplatelet treatment
Key secondary outcomes	Hemorrhagic event Stent thrombosis Major adverse cardiac event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Aspirin group
Interventions/Control_2	Clopidogrel group
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) Coronary artery disease patients implanted DES at our institute 2) Patients continuing DAPT after PCI 3) Patients capable of using OCT at the follow up CAG 4) Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study
Key exclusion criteria	1) Patients with cardiovascular shock 2) Patients with a history of stent thrombosis 3) Patients who is impossible to be followed up at our institute 4) Patients scheduled to have PCI or bypass surgery 5) Patients who are treated with thienopyridine for secondary prevention of cerebrovascular event 6) Pregnant or possibly pregnant 7) Life expectancy <1 year 8) Patients after PCI 9) Patients who were judged inappropriate by the principal investigator
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsushi Kikuchi
Organization	Osaka General Medical Center
Division name	Department of Cardiology
Zip code
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL	06-6692-1201
Email	kenkyusien@gh.opho.jp

Public contact
Name of contact person	1st name Middle name Last name Atsushi Kikuchi
Organization	Osaka General Medical Center
Division name	Department of Cardiology
Zip code
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL	06-6692-1201
Homepage URL
Email	kenkyusien@gh.opho.jp

Sponsor
Institute	Osaka General Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2014 Year 04 Month 15 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	Completed
Date of protocol fixation	2012 Year 11 Month 20 Day
Date of IRB	2012 Year 12 Month 11 Day
Anticipated trial start date	2013 Year 01 Month 31 Day
Last follow-up date	2014 Year 12 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	2014 Year 04 Month 15 Day
Last modified on	2019 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016018