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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020783
Receipt No. 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

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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
Email 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
Email shokimot@kumamoto-u.ac.jp

Sponsor
Institute Graduate School of Medical Sciences, Kumamoto University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023930

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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