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 |
PREVENTion of Contrast-Induced Nephropathy after Cardiovascular catheterization and intervention by high dose statin therapy in Japan
PREVENTion of Contrast-Induced Nephropathy after Cardiovascular catheterization and intervention by high dose statin therapy in Japan (Prevent CINC-J study)
PREVENTion of Contrast-Induced Nephropathy after Cardiovascular catheterization and intervention by high dose statin therapy in Japan
PREVENTion of Contrast-Induced Nephropathy after Cardiovascular catheterization and intervention by high dose statin therapy in Japan (Prevent CINC-J study)
Japan |
Coronary artery disease with dyslipidemia and chronic kidney disease
Medicine in general | Cardiology | Nephrology |
Radiology |
Others
NO
To evaluate the effect of high dose statin therapy in preventing contrast induced nephropathy after cardiovascular catheterization and intervention
Safety,Efficacy
Exploratory
Contrast-induced nephropathy; an increase in serum creatinine level of 0.5 mg/dL or 25% at 48 hours after contrast medium exposure
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Prevention
Medicine |
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
Conventional treatment
Standard hydration with sodium chloride plus single bolus intravenous administration of sodium bicarbonate (20 mEq)
20 | years-old | <= |
Not applicable |
Male and Female
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
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
420
1st name | Yoshihiko |
Middle name | |
Last name | Saito |
Nara Medical University
Department of Cardiovascular Medicine
634-8521
840 Shijocho Kashihara Nara
0744-22-3051
saitonaramed@gmail.com
1st name | Makoto |
Middle name | |
Last name | Makoto Watanabe |
Prevent CINC-J study group
Department of Cardiovascular Medicine, Nara Medical University
634-8521
840 Shijocho Kashihara Nara
0744-22-3051
prevent-cinc-j@naramed-u.ac.jp
Nara Medical University
Abbott Japan Corporation
Profit organization
Nara Medical University Hospital Institutional Review Board
840,Shijo-cho,Kashihara-city,Nara
0744-22-3051
ychiken@naramed-u.ac.jp
NO
2016 | Year | 05 | Month | 09 | Day |
Unpublished
Completed
2016 | Year | 03 | Month | 30 | Day |
2016 | Year | 06 | Month | 01 | Day |
2016 | Year | 05 | Month | 09 | Day |
2019 | Year | 11 | Month | 04 | Day |
2021 | Year | 06 | Month | 30 | Day |
2016 | Year | 03 | Month | 30 | Day |
2022 | Year | 11 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024989