Contrast-Induced NephropathyPhase 2/3NCT02114346
High Dose Atorvastatin for Preventing Contrast-induced Nephropathy
A Phase 2/3 study testing Atorvastatin and 0.9% sodium chloride in people with Contrast-Induced Nephropathy, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to determine the efficacy of atorvastatin in the prevention of contrast-induced nephropathy in patients undergoing computed tomography coronary angiography. Investigators assume that atorvastatin is effective in this regard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-Induced Nephropathy
- What is being tested?
- Atorvastatin and 0.9% sodium chloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteIran
- Study dates
- Jul 2013to Feb 2014
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients
- candidate of elective computed tomography angiogram
- willingness to participate
Who cannot join
- unstable angina or myocardial infarction, cardiac arrhythmia, seizures, acute renal failure, end-stage renal disease
- unstable serum creatinine
- unstable hemodynamic
- intravascular administration of contrast material in the past month
- using high dose atorvastatin in the past month,
- known hypersensitivity to atorvastatin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effect of High Dose Atorvastatin (80 mg/d) Comparing With Placebo in Preventing Contrast-induced Nephropathy in Patients Undergoing Computed Tomography Coronary Angiography
The aim of this study is to determine the efficacy of atorvastatin in the prevention of contrast-induced nephropathy in patients undergoing computed tomography coronary angiography. Investigators assume that atorvastatin is effective in this regard. Investigators include patients referring for elective computed tomography coronary angiography and allocate them to atorvastatin or placebo from 24 hours before to 48 hours after administration of contrast material. Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL or ≥ 25% of the baseline value.
- Conditions
- Contrast-Induced Nephropathy
- Being tested
- Atorvastatin, Placebo, 0.9% sodium chloride
- Keywords
- Computed Tomography Angiogram, Side Effects, Contrast-Induced Nephropathy, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
PlaceboDrug
0.9% sodium chlorideDrug
Patients with estimated glomerular filtration rate of less than 60 mL/min/1.73 m2 are hydrated with 0.9% sodium chloride for 2 hours, from 1 hour before (3 mL/kg/hour) to 1 hour after (1 mL/kg/hour) operation. Patients with left ventricular ejection fraction less than 40% or New York Heart Association functional class III-IV, are hydrated with 0.5 mL/kg/hour.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Patients in the atorvastatin group receive 80 mg atorvastatin (2 x atorvastatin 40 mg tablets) once daily from 24 hours before to 48 hours after administration of contrast material. Receives: Drug: Atorvastatin; Drug: 0.9% sodium chloride |
| Placebo | Placebo comparator | Patients in the placebo group receive 2 placebo tablets once daily from 24 hours before to 48 hours after administration of contrast material. Receives: Drug: Placebo; Drug: 0.9% sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma creatinine level
Plasma creatinine level is measured at baseline and after 48 hours of contrast injection. Increase in plasma creatinine level ≥ 0.5 mg/dL or ≥ 25% of the baseline creatinine after 48 hours of contrast injection will be considered contrast induced nephropathy.
Measured: up to 48h after contrast injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alireza Hajian Nejad, Isfahan University of Medical Sciences
- Investigators
- Alireza Hajian, M.D., Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114346
- Sponsor's protocol ID
- 392353
- Status last verified
- Apr 2014
- First submitted
- 11 Apr 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Li Y, Liu Y, Fu L, Mei C, Dai B. Efficacy of short-term high-dose statin in preventing contrast-induced nephropathy: a meta-analysis of seven randomized controlled trials. PLoS One. 2012;7(4):e34450. doi: 10.1371/journal.pone.0034450. Epub 2012 Apr 12.
PubMed 22511942
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of High Dose Atorvastatin (80 mg/d) Comparing With Placebo in Preventing Contrast-induced Nephropathy in Patients Undergoing Computed Tomography Coronary Angiography
- ClinicalTrials.gov ID
- NCT02114346
- Acronym / sponsor ID
- 392353
- Conditions
- Contrast-Induced Nephropathy
- Keywords
- Computed Tomography Angiogram, Side Effects, Contrast-Induced Nephropathy, Prevention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Apr 2014 (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.
The aim of this study is to determine the efficacy of atorvastatin in the prevention of contrast-induced nephropathy in patients undergoing computed tomography coronary angiography. Investigators assume that atorvastatin is effective in this regard. Investigators include patients referring for elective computed tomography coronary angiography and allocate them to atorvastatin or placebo from 24 hours before to 48 hours after administration of contrast material. Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL or ≥ 25% of the baseline value.
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 |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatin, Drug: 0.9% sodium chloridePatients in the atorvastatin group receive 80 mg atorvastatin (2 x atorvastatin 40 mg tablets) once daily from 24 hours before to 48 hours after administration of contrast material. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: 0.9% sodium chloridePatients in the placebo group receive 2 placebo tablets once daily from 24 hours before to 48 hours after administration of contrast material. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients
- candidate of elective computed tomography angiogram
- willingness to participate
Key exclusion criteria (6 listed)
- unstable angina or myocardial infarction, cardiac arrhythmia, seizures, acute renal failure, end-stage renal disease
- unstable serum creatinine
- unstable hemodynamic
- intravascular administration of contrast material in the past month
- using high dose atorvastatin in the past month,
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 |
|---|---|---|
| Atorvastatin | Drug | Atorvastatin |
| Placebo | Drug | Placebo |
| 0.9% sodium chloridePatients with estimated glomerular filtration rate of less than 60 mL/min/1.73 m2 are hydrated with 0.9% sodium chloride for 2 hours, from 1 hour before (3 mL/kg/hour) to 1 hour after (1 mL/kg/hour) operation. Patients with left ventricular ejection fraction less than 40% or New York Heart Association functional class III-IV, are hydrated with 0.5 mL/kg/hour. | Drug | Atorvastatin, Placebo |
Primary outcome
Plasma creatinine level
Time frame: up to 48h after contrast injection
Plasma creatinine level is measured at baseline and after 48 hours of contrast injection. Increase in plasma creatinine level ≥ 0.5 mg/dL or ≥ 25% of the baseline creatinine after 48 hours of contrast injection will be considered contrast induced nephropathy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Background: PubMed 22511942Li Y, Liu Y, Fu L, Mei C, Dai B. Efficacy of short-term high-dose statin in preventing contrast-induced nephropathy: a meta-analysis of seven randomized controlled trials. PLoS One. 2012;7(4):e34450. doi: 10.1371/journal.pone.0034450. Epub 2012 Apr 12.
Related trials for Contrast-Induced Nephropathy
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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)
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Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
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Contrast-associated Acute Kidney Injury
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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.
Alireza Hajian, M.D. principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Atorvastatin and 0.9% sodium chloride in people with Contrast-Induced Nephropathy, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 15 Apr 2014. 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 Iran. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma creatinine level (time frame: up to 48h after contrast injection). 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 NCT02114346, 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 15 Apr 2014.