NephropathySCINNCT01071993
Efficacy of Statins In Prevention of CIN
A study testing atorvastatin in people with Nephropathy, run by University of Oklahoma at 2 sites in United States.
Trial summary
To determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Nephropathy
- What is being tested?
- atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Inclusion Criteria:
- Adults > 18 years of age
- undergoing coronary or peripheral angiography with or without intervention
- Cr > 1.3 mg/dL or GFR < 60 mL/min
- Exclusion Criteria:
- end-stage renal disease on dialysis
- acute renal failure
- previous iodinated contrast media exposure within 7 days of study entry
- history of hypersensitivity to statins
- pregnancy or lactation
- emergent coronary angiography, ST elevation myocardial infarction (STEMI), or cardiogenic shock
- prisoners
- patients already on maximum dose of statins
- patient receiving N-acetylcysteine or sodium bicarbonate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, 73104
Veterans Affairs Medical Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Efficacy Of Statins In The Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Insufficiency (SCIN Trial): A Double-Blind, Placebo-Controlled Trial
To determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.
Read the detailed description
Due to the conflict in the available data, there are no practice guidelines that are established in order to prevent contrast-induced nephropathy (CIN). Our goal is to determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.
- Conditions
- Nephropathy
- Being tested
- placebo, atorvastatin
- Keywords
- prevention, nephropathy
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
atorvastatinDrug
pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
| Study group | Role | What they receive |
|---|---|---|
| atorvastatin | Active comparator | Not described Receives: Drug: atorvastatin |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours.
Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 \& at 48 Hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Sponsor can not supply drugs anymore.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NephropathyStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mazen Abu-Fadel, M.D., Principal investigator, Oklahoma Univeristy Health Science Center and VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071993
- Sponsor's protocol ID
- 15097
- Acronym
- SCIN
- Status last verified
- Oct 2017
- First submitted
- 18 Feb 2010
- Last updated
- 4 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No data was collected; therefore, a plan is not applicable.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Statins In The Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Insufficiency (SCIN Trial): A Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT01071993
- Acronym / sponsor ID
- SCIN / 15097
- Conditions
- Nephropathy
- Keywords
- prevention, nephropathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor can not supply drugs anymore.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Posted 13 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.
Detailed description
Due to the conflict in the available data, there are no practice guidelines that are established in order to prevent contrast-induced nephropathy (CIN). Our goal is to determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atorvastatin | Active comparator | Drug: atorvastatin |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| placebopre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) | Drug | placebo |
| atorvastatinpre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) | Drug | atorvastatin |
Primary outcome
Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours.
Time frame: 48 hours
Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 \& at 48 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No data was collected; therefore, a plan is not applicable.
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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.
Mazen Abu-Fadel, M.D. principal investigator
Oklahoma Univeristy Health Science Center and VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atorvastatin in people with Nephropathy, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2017.