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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013719
Receipt No. R000016018
Scientific Title Coronary intervention and optimal AntiPlatelet Therapy-Optical coherence tomography study-
Date of disclosure of the study information 2014/04/15
Last modified on 2019/10/18

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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