UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020452 |
|---|---|
| Receipt number | 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 | 2024/08/02 10:42:55 |
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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
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
ueda.yasunori.ju@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Osaka National Hospital
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2024 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023601
