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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020452
Receipt No. R000023601
Scientific Title Drug-Eluting Stent Failure prevention by Aggressive Statin therapy trial
Date of disclosure of the study information 2016/01/18
Last modified on 2020/01/08

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Basic information
Public title Drug-Eluting Stent Failure prevention by Aggressive Statin therapy trial
Acronym Drug-Eluting Stent Failure prevention by Aggressive Statin therapy trial
Scientific Title Drug-Eluting Stent Failure prevention by Aggressive Statin therapy trial
Scientific Title:Acronym Drug-Eluting Stent Failure prevention by Aggressive Statin therapy trial
Region
Japan

Condition
Condition Coronary heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine if the aggressive statin treatment is more effective to prevent very-late DES failure than the standard statin treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Very-late DES failure (cardiac death or TLR) at 5 years
Key secondary outcomes

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 The aggressive statin treatment, targeted at LDL-C < 70mg/dl, for 5 years.
Interventions/Control_2 The standard statin treatment, targeted at LDL-C < 100mg/dl, for 5 years
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 Patients who received PCI with DES.
Key exclusion criteria None.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Yasunori
Middle name
Last name Ueda
Organization National Hospital Organization Osaka National Hospital
Division name Cardiovascular Division
Zip code 540-0006
Address 2-1-14 Hoenzaka, Chuo-ku, Osaka, OSAKA 540-0006, JAPAN
TEL +81-6-6942-1331
Email ueda.yasunori.ju@mail.hosp.go.jp

Public contact
Name of contact person
1st name Yasunori
Middle name
Last name Ueda
Organization National Hospital Organization Osaka National Hospital
Division name Cardiovascular Division
Zip code 540-0006
Address 2-1-14 Hoenzaka, Chuo-ku, Osaka, OSAKA 540-0006, JAPAN
TEL +81-6-6942-1331
Homepage URL
Email ueda.yasunori.ju@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Osaka National Hospital
Institute
Department

Funding Source
Organization Abbott Vascular Japan
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 National Hospital Organization Osaka National Hospital
Address 2-1-14 Hoenzaka, Chuo-ku, Osaka, OSAKA 540-0006, JAPAN
Tel +81-6-6942-1331
Email 408-chiken@mail.hosp.go.jp

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 18 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 Enrolling by invitation
Date of protocol fixation
2015 Year 12 Month 18 Day
Date of IRB
2015 Year 09 Month 29 Day
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
2025 Year 01 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
2016 Year 01 Month 06 Day
Last modified on
2020 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023601

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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