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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021695
Receipt No. 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 2019/10/17

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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
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 Open public recruiting
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

Other
Other related information

Management information
Registered date
2016 Year 03 Month 30 Day
Last modified on
2019 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024989

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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