Prevent CINC-J study

JRCT ID: jRCTs051180189

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Contrast-Induced Nephropathy
• Date of first enrollment: 27/07/2016
• Target sample size: 420
• Study type: Interventional
• Intervention(s): 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

Outcome(s)

Primary Outcome

1) Contrast-induced nephropathy; an increase in serum creatinine level of 0.5 mg/dL or 25% at 48 hours after contrast medium exposure
2) Main Safety Evaluations
Presence of muscle pain, drug eruption, nausea, an increase in GOT or GPT level of 100 IU/L or more, in CPK level of 350 IU/L or more

Secondary Outcome

1) Acute kidney injury; an increase in serum creatinine level of 0.3 mg/dL or more, or 50% or more at 48 hours after contrast medium exposure
2) Extent of 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) Cardiovascular events within 12 months (all cause death, cardiac death, myocardial infarction, stroke, and hospitalization for heart failure)
5) Renal events within 12 months (Initiation of dialysis, and more than twice of baseline serum creatinine level)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Age>=20 years old
2) eGFR<60ml/min/1.73 m2, or proteinuria (qualitative 1+, or more)
3) LDL>=120mg/dL (primary prevention of cardiovascular disease)
4) LDL>=100mg/dL (secondary prevention of cardiovascular disease)
5) Patients taking statin
6) Patients who can take internal statin
7) Written informed consent

Exclude criteria

1) Contraindication to statin treatment
2) Contraindication to contrast medium
3) Patients receiving fibrates
4) Patients receiving cyclosporine
5) Severe liver dysfunction (acute hepatitis, acute exacerbation of chronic hepatitis, liver cancer, jaundice, GOT or GPT of 100IU/l, or more)
6) Severe renal dysfunction (acute renal failure, maintenance dialysis, SCr of 3mg/dl, or more)
7) Severe thyroid disease
8) CPK of 350 IU/l, or more at registration
9) Patients receiving high dose statin (atorvastatine of 15mg/day, or more; rosvastatin of 7.5mg/day, or more; pitavastatin of 3mg/day, or more) at registration
10) Familial hypercholesterolemia
11) Nephrotic syndrome
12) Intravenous contrast medium administration within the previous 10 days
13) Patients in participating in other clinical trials
14) Pregnant, becoming pregnant, breast feeding
15) Patients of not able or willing to adhere to the study visit schedule
16) Inadequate to this study

Related Information

• Primary Sponsor: Saito Yoshihiko
• Source(s) of Monetary Support: ABBOTT JAPAN CO., LTD.
• Secondary ID(s): UMIN000021695