UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013719 |
|---|---|
| Receipt number | 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 09:08:59 |
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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
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
kenkyusien@gh.opho.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016018
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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