Contrast-induced NephropathyPhase 4NCT01871792
Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction
A Phase 4 study testing Pitavastatin in people with Contrast-induced Nephropathy, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
Contrast-induced nephropathy (CIN) is a well-recognized complication of radiographic contrast administration and is associated with increased short- and long-term mortality. Previous strategies including forced diuresis with diuretics or mannitol, intravenous administration of fenoldopam or dobutamine, and… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Contrast-induced Nephropathy
- What is being tested?
- Pitavastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Feb 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years
- Need for coronary angiography or intervention in patients with typical symptoms for angina or myocardial infarction, or documented myocardial ischemia at non-invasive studies including ECG, treadmill ECG test, heart spect or coronary CT angiography
- Estimated glomerular filtration rate ≤60 mL/min
- Informed consent
Who cannot join
- Need for primary percutaneous coronary intervention or emergent intervention in patients with myocardial infarction
- Allergic reaction for contrast agent (Visipaque) or statin
- Contraindication for contrast agent (Visipaque) or statin
- Shock status fron any cause including cardiogenic shock
- Statin use before enrollment (Enrollment after 2 weeks of wash-out period)
- Exposure of contrast agent within 7 days before enrollment
Show all 18Show fewer
- Pregnancy or Expectation for pregnancy in women of childbearing age
- Heart failure (NYHA class ≥3 or left ventricular ejection fraction < 40%)
- Acute renal injury
- Dialysis therapy
- Mechanical ventilator
- Life expectancy < 6 months
- Non-steroidal anti-inflammatory drug, dopamine, mannitol or N-acetylcysteine, ascorbic acid within 48 hours before and after coronary angiography/intervention
- Severe hepatic dysfunction
- Eisenmenger syndrome or idiopathic pulmonary hypertension
- Renal artery angioplasty within 6 months
- Single functioning kidney
- Kidney transplantation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gachon University Gil Hospital
Incheon, 405-760
Woong Chul Kang, M.D., +82-32-460-3663, kangwch@gilhospital.com
About this study
Official title: Preventive Effect of the PRetreatment With pItavastatiN on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndErgoing Coronary Angiography/Intervention (PRINCIPLE-II Study)
Contrast-induced nephropathy (CIN) is a well-recognized complication of radiographic contrast administration and is associated with increased short- and long-term mortality. Previous strategies including forced diuresis with diuretics or mannitol, intravenous administration of fenoldopam or dobutamine, and postprocedure hemodialysis to prevent CIN have been largely unsuccessful. In addition, the use of N-acetylcysteine to prevent CIN has yielded conflicting outcomes.
A review of a large insurance database and retrospective study have shown that statins therapy is associated with a lower incidence of CIN after percutaneous coronary intervention. The preventive effect of statins on CIN may be attributed to direct pleiotropic effects on the vascular wall such as improvement of endothelial dysfunction, anti-inflammatory or anti-oxidative effect. However, recent randomized trial could not demonstrate the preventive effect of statin on CIN in patients with chronic kidney disease.
Thus, we will investigate the preventive effect of pitavastatin on CIN in patient with renal dysfunction undergoing coronary angiography or intervention.
- Conditions
- Contrast-induced Nephropathy
- Being tested
- Pitavastatin, Placebo
- Keywords
- Contrast-induced nephropathy, Prevention, Statin, Pitavastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
Also called Livalo®
PlaceboDrug
Sugar pill manufactured to mimic Pitavastatin 4 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin | Experimental | Pitavastatin 4 mg/day for 7 days before coronary angiography/intervention Receives: Drug: Pitavastatin |
| Placebo | Placebo comparator | Placebo tablet for 7 days before coronary angiography/intervention Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of contrast-induced nephropathy
Contrast-induced nephropathy is defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0.5 mg/dL after coronary angiography or intervention.
Measured: 48 hours
Secondary outcomes (5)
Peak level of serum creatinine
Peak level of serum creatinine within less than 48 hours after coronary angiography or intervention
Measured: 48 hours
serum cystatin-C level
Absolute level of serum cystatin-C 24 hours after coronary angiography/intervention and Difference level of serum cystatin-C before and after coronary angiography/intervention
Measured: 24 hours
serum neutrophil-gelatinase-associated lipocalin(NGAL) level
Absolute level of serum NGAL level 4 hours after coronary angiography/intervention and difference level before and after coronary angiography/intervention
Measured: 4 hours
Length of hospital stay
Measured: an expected average of 5 weeks
Clinical events
Composites of death, myocardial infarction, stroke or need for dialysis therapy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contrast-induced NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gangnam Severance Hospital, Severance Hospital, National Health Insurance Service Ilsan Hospital, Myongji Hospital, Bundang CHA Hospital, Inje University, Dankook University, Eulji General Hospital
- Responsible party
- Principal investigator, Woong Chol Kang, Gachon University Gil Medical Center
- Investigators
- Woong Chul Kang, M.D., Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871792
- Sponsor's protocol ID
- PRINCIPLE-II
- Status last verified
- Jun 2013
- First submitted
- 25 May 2013
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kang WC, Kim M, Park SM, Kim BK, Lee BK, Kwon HM. Preventive Effect of Pretreatment with Pitavastatin on Contrast-Induced Nephropathy in Patients with Renal Dysfunction Undergoing Coronary Procedure: PRINCIPLE-II Randomized Clinical Trial. J Clin Med. 2020 Nov 17;9(11):3689. doi: 10.3390/jcm9113689.
PubMed 33213012
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effect of the PRetreatment With pItavastatiN on Contrast-Induced Nephropathy in Patients With RenaL Dysfunction UndErgoing Coronary Angiography/Intervention (PRINCIPLE-II Study)
- ClinicalTrials.gov ID
- NCT01871792
- Acronym / sponsor ID
- PRINCIPLE-II
- Conditions
- Contrast-induced Nephropathy
- Keywords
- Contrast-induced nephropathy, Prevention, Statin, Pitavastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Collaborators
- Gangnam Severance Hospital, Severance Hospital, National Health Insurance Service Ilsan Hospital, Myongji Hospital, Bundang CHA Hospital, Inje University, Dankook University, Eulji General Hospital
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Contrast-induced nephropathy (CIN) is a well-recognized complication of radiographic contrast administration and is associated with increased short- and long-term mortality. Previous strategies including forced diuresis with diuretics or mannitol, intravenous administration of fenoldopam or dobutamine, and postprocedure hemodialysis to prevent CIN have been largely unsuccessful. In addition, the use of N-acetylcysteine to prevent CIN has yielded conflicting outcomes.
A review of a large insurance database and retrospective study have shown that statins therapy is associated with a lower incidence of CIN after percutaneous coronary intervention. The preventive effect of statins on CIN may be attributed to direct pleiotropic effects on the vascular wall such as improvement of endothelial dysfunction, anti-inflammatory or anti-oxidative effect. However, recent randomized trial could not demonstrate the preventive effect of statin on CIN in patients with chronic kidney disease.
Thus, we will investigate the preventive effect of pitavastatin on CIN in patient with renal dysfunction undergoing coronary angiography or intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin | Experimental | Drug: PitavastatinPitavastatin 4 mg/day for 7 days before coronary angiography/intervention |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet for 7 days before coronary angiography/intervention |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 19 years
- Need for coronary angiography or intervention in patients with typical symptoms for angina or myocardial infarction, or documented myocardial ischemia at non-invasive studies including ECG, treadmill ECG test, heart spect or coronary CT angiography
- Estimated glomerular filtration rate ≤60 mL/min
- Informed consent
Key exclusion criteria (18 listed)
- Need for primary percutaneous coronary intervention or emergent intervention in patients with myocardial infarction
- Allergic reaction for contrast agent (Visipaque) or statin
- Contraindication for contrast agent (Visipaque) or statin
- Shock status fron any cause including cardiogenic shock
- Statin use before enrollment (Enrollment after 2 weeks of wash-out period)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PitavastatinAlso: Livalo® | Drug | Pitavastatin |
| PlaceboSugar pill manufactured to mimic Pitavastatin 4 mg tablet | Drug | Placebo |
Primary outcome
Incidence of contrast-induced nephropathy
Time frame: 48 hours
Contrast-induced nephropathy is defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0.5 mg/dL after coronary angiography or intervention.
5 secondary outcomes
Peak level of serum creatinine
Time frame: 48 hours
serum cystatin-C level
Time frame: 24 hours
serum neutrophil-gelatinase-associated lipocalin(NGAL) level
Time frame: 4 hours
Length of hospital stay
Time frame: an expected average of 5 weeks
Clinical events
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
- Derived from this study: PubMed 33213012Kang WC, Kim M, Park SM, Kim BK, Lee BK, Kwon HM. Preventive Effect of Pretreatment with Pitavastatin on Contrast-Induced Nephropathy in Patients with Renal Dysfunction Undergoing Coronary Procedure: PRINCIPLE-II Randomized Clinical Trial. J Clin Med. 2020 Nov 17;9(11):3689. doi: 10.3390/jcm9113689.
Related trials for Contrast-induced Nephropathy
Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
Not yet recruitingObservational study
Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
Not yet recruitingObservational study
An Observational Study of Percutaneous Glomerular Filtration Rate (TGFR) in the Early Warning of Contrast-induced Acute Kidney Injury During the Peri-examination Period of Emergency Enhanced CT
Contrast-associated Acute Kidney Injury
Not yet recruitingObservational study
Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
Not yet recruitingObservational study
Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
Contrast-Associated Acute Kidney Injury, Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woong Chul Kang, M.D. principal investigator
Gachon University Gil Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pitavastatin in people with Contrast-induced Nephropathy, run by Gachon University Gil Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Woong Chul Kang, M.D. (+82-32-460-3663, kangwch@gilhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of contrast-induced nephropathy (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01871792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2013.