UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020783 |
|---|---|
| Receipt number | R000023930 |
| Scientific Title | Real-world evaluation of optimal medical therapy after percutaneous coronary intervention. |
| Date of disclosure of the study information | 2016/01/28 |
| Last modified on | 2017/01/28 09:07:38 |
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Basic information
Public title
Real-world evaluation of optimal medical therapy after percutaneous coronary intervention.
Acronym
Real-world evaluation of optimal medical therapy after percutaneous coronary intervention.
Scientific Title
Real-world evaluation of optimal medical therapy after percutaneous coronary intervention.
Scientific Title:Acronym
Real-world evaluation of optimal medical therapy after percutaneous coronary intervention.
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of medical therapy including anti-platelets in patients undergoing percutaneos coronary intervention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major adverse cardiac event (MACE), including cardiovascular death, non-fatal myocardial infarction, stroke, stent thrombosis, unstable angina and admission due to ischemic heart failure
Key secondary outcomes
Hemorrhagic event rates
Interruption rates of medical therapy
P2Y12 reaction unit
Neointimal thickening
Existence of coronary thrombus at follow-up time
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent percutaneous coronary intervention in study institutions and were registered in Kumamoto Intervention Conference Study (KICS) registry and who agreed with participant in this study with consent documents
Key exclusion criteria
Patiens who did not agree or who met exclusion criteria as follows:
1) Patients without implantation of coronary stents (balloon angioplasty only)
2) With residual stenosis >50%, died during admission, critical complications such as subacute stent thrombosis during admission or patients with emergent coronary artery bypass grafting surgery
3) Others
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Hokimoto |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1, Honjo, Chuo-ku, Kumamoto City
TEL
81-96-373-5175
shokimot@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Hokimoto |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1, Honjo, Chuo-ku, Kumamoto City
TEL
81-96-373-5175
Homepage URL
shokimot@kumamoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | Year | 01 | Month | 28 | 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
| 2016 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: cohort study
Recruitment: Patients undergoing PCI registered in the KICS (Kumamoto Intervention Conference Study) registry
Management information
Registered date
| 2016 | Year | 01 | Month | 28 | Day |
Last modified on
| 2017 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023930
| 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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| Registered date | File name |
