UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012388 |
|---|---|
| Receipt number | R000014486 |
| Scientific Title | Effect of statin for trans-catheter aortic valve implantation |
| Date of disclosure of the study information | 2013/11/23 |
| Last modified on | 2018/11/28 15:57:23 |
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Basic information
Public title
Effect of statin for trans-catheter aortic valve implantation
Acronym
ES-TAVI
Scientific Title
Effect of statin for trans-catheter aortic valve implantation
Scientific Title:Acronym
ES-TAVI
Region
| Japan |
Condition
Condition
Aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Main purpose of this study is to investigate effect of statin for peri-procedual, post procedural outcome and long term valve condition after TAVI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
MI
Cardiac/non cardiac death
stroke
Unplanned pacemaker implantation
unplanned open chestsurgery
Unplanned peripheral vascular intervention/surgical repair
Life thretening bleeding
Unplanned admossion due to valve failure
Acute renal injury with 3-fold increment of serum cretinine level
Key secondary outcomes
Pressure Gradient
Aortic valve Area
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pravastatin group
Interventions/Control_2
Standard 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
| 60 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients to who TAVI is scheduled.
Patient who has severe AS and symptomatic. AVA is 18-28mm. Distance between annulus-coronary artery>10mm. Creatinine level<2.0mg/dl, Expected life expenctency >1y, Indication for TAVI is decided by heart team.
2) Normal LDL and high LDL patients
LDL level must be higher than 50mg/dl in 2 measurements. If less than 50mg/dl, 3rd measurement is allowed. Average LDL level must be higher than 50mg/dl.
Key exclusion criteria
1) Familial hypercholesteremia
2) Previous TAVI
3) Congenital heart disease
4)Severe liver dysfunction or renal dysfunction
5) Nephrotic syndrome
6) Hypothyroidism
7) Cusing syndrome
8) Steroid therapy
9) Past history of allergic reaction for statins
10) pregnant female
11) Unconsented by patients or therapist
12) Patients who has been treated with statins for coronary artery diseases
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Mitsuhashi |
Organization
St Luke's International Hospital
Division name
Cardivascular Center
Zip code
Address
9-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-3541-5151
mitsuhashi3615@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Mitsuhashi |
Organization
St Luke's International Hospital
Division name
Cardiovascular Center
Zip code
Address
Same as above
TEL
03-3541-5151
Homepage URL
mitsuhashi3615@yahoo.co.jp
Sponsor or person
Institute
St Luke's International Hospital Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
St Luke's International Hospital Cardiovascular Center
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
| 2013 | Year | 11 | Month | 23 | 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
| 2013 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 15 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 23 | Day |
Last modified on
| 2018 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014486
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| Registered date | File name |
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| Registered date | File name |
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