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 - PREVENTion of Contrast-Induced Nephropathy after Cardiovascular catheterization and intervention by high dose statin therapy in Japan (Prevent CINC-J study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021695

Enrollment

420

Registered

2016-05-09

Start date

2016-05-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease with dyslipidemia and chronic kidney disease

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Contrast-induced nephropathy; an increase in serum creatinine level of 0.5 mg/dL or 25% at 48 hours after contrast medium exposure	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactMakoto Makoto Watanabe

Prevent CINC-J study group Department of Cardiovascular Medicine, Nara Medical University

prevent-cinc-j@naramed-u.ac.jp0744-22-3051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026