UMIN-CTR Clinical Trial

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
Email	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
Email	prevent-cinc-j@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024989