UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021695 |
|---|---|
| Receipt number | R000024989 |
| Scientific Title | PREVENTion of Contrast-Induced Nephropathy after Cardiovascular catheterization and intervention by high dose statin therapy in Japan |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2022/11/09 16:22:01 |
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Basic information
Public title
PREVENTion of Contrast-Induced Nephropathy after Cardiovascular catheterization and intervention by high dose statin therapy in Japan
Acronym
PREVENTion of Contrast-Induced Nephropathy after Cardiovascular catheterization and intervention by high dose statin therapy in Japan (Prevent CINC-J study)
Scientific Title
PREVENTion of Contrast-Induced Nephropathy after Cardiovascular catheterization and intervention by high dose statin therapy in Japan
Scientific Title:Acronym
PREVENTion of Contrast-Induced Nephropathy after Cardiovascular catheterization and intervention by high dose statin therapy in Japan (Prevent CINC-J study)
Region
| Japan |
Condition
Condition
Coronary artery disease with dyslipidemia and chronic kidney disease
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of high dose statin therapy in preventing contrast induced nephropathy after cardiovascular catheterization and intervention
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Contrast-induced nephropathy; an increase in serum creatinine level of 0.5 mg/dL or 25% at 48 hours after contrast medium exposure
Key secondary outcomes
1) Acute kidney injury; an increase in serum creatinine level of 0.3 mg/dL or 50% at 48 hours after contrast medium exposure
2) Change in serum creatinine level 24 hours and 48 hours after coronary angiography
3) Urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) level and urinary NGAL/ urinary creatinine on the day, 24 hours and 48 hours after coronary angiography
4) All cause death, cardiac death, stroke, and hospitalization for heart failure at 12 moths
5) Newly required dialysis and more than 2 x baseline serum creatinine level at 12 months
6) Adverse drug reaction; myalgia, eczema, nausea, elevation of GOT or GPT, elevation of CPK
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
Additional treatment
Standard hydration with sodium chloride plus single bolus intravenous administration of sodium bicarbonate (20 mEq) and short-term high dose pitavastatin (4mg/day x 4days) therapy
Interventions/Control_2
Conventional treatment
Standard hydration with sodium chloride plus single bolus intravenous administration of sodium bicarbonate (20 mEq)
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 undergoing elective coronary angiography satisfied following inclusion criteria
1. Age>=20 years old
2. eGFR<60ml/min/1.73 m2 or proteinuria
3. Taking statin or LDL>=120 without coronary artery disease or LDL>=100 with coronary artery disease.
4. Written informed consent
Key exclusion criteria
1. Contraindication to statin treatment
2. Contraindication to contrast medium
3. Treatment with fibrate
4. Treatment with cyclosporine
5. Severe liver dysfunction (acute hepatitis, liver cirrhosis, liver cancer, jaundice, GOT or GPT>=100IU/l)
6. Severe renal dysfunction (acute renal failure, maintenance dialysis, serum creatinine>=3mg/dl)
7. CPK>=350IU/L
8. Patients receiving high dose statin (atorvastatine;>=15mg/day,rosvastatin;>=7.5mg/day,pitavastatin;>=3mg/day) before enrollment
9. Familial hypercholesterolemia
10. Nephrotic syndrome
11. Contrast medium administration within the previous 10 days
12. Pregnant, becoming pregnant, breast feeding
13. Inadequate to this study
Target sample size
420
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Saito |
Organization
Nara Medical University
Division name
Department of Cardiovascular Medicine
Zip code
634-8521
Address
840 Shijocho Kashihara Nara
TEL
0744-22-3051
saitonaramed@gmail.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Makoto Watanabe |
Organization
Prevent CINC-J study group
Division name
Department of Cardiovascular Medicine, Nara Medical University
Zip code
634-8521
Address
840 Shijocho Kashihara Nara
TEL
0744-22-3051
Homepage URL
prevent-cinc-j@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Abbott Japan Corporation
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
Nara Medical University Hospital Institutional Review Board
Address
840,Shijo-cho,Kashihara-city,Nara
Tel
0744-22-3051
ychiken@naramed-u.ac.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 | 05 | Month | 09 | 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
| 2016 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 30 | Day |
Last modified on
| 2022 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024989
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