Contrast Induced NephropathyPhase 3CINNCT02113540
Assessment of the Effect of Atorvastatin on Prevention of CIN in Patients Undergoing Coronary Angiography
A Phase 3 study testing Atorvastatin in people with Contrast Induced Nephropathy, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
As the effect of statin use before the angiography to prevent contrast induced nephropathy (CIN) is not well-known, the aim of the current study is to assess the effect of atorvastatin on prevention of CIN in patients undergoing coronary angiography. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Contrast Induced Nephropathy
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Jan 2012to May 2014
- Phase
- Phase 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- having chronic stable angina who were referred for coronary angiography
- non-pregnant female subjects
- no history of diabetes mellitus
- no history of renal failure
- no history of single kidney
- no history of cardiogenic shock
Show all 10Show fewer
- no history of unstable angina
- no history of myocardial infarction
- no history of hypersensitivity to statins
- no history of previous intravascular contrast injection during one month before admission
Who cannot join
- glomerular filtration rate (GFR) <60
- cardiogenic shock
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Study site
Isfahan, Isfahan
payman bidram, resident, MD, 0989131102802, pbidram2000@yahoo.com
About this study
Official title: Atorvastatin and Prevention of Contrast Induced Nephropathy Following Coronary Angiography
As the effect of statin use before the angiography to prevent contrast induced nephropathy (CIN) is not well-known, the aim of the current study is to assess the effect of atorvastatin on prevention of CIN in patients undergoing coronary angiography.
- Conditions
- Contrast Induced Nephropathy
- Being tested
- Atorvastatin
- Keywords
- coronary angiography, chronic stable angina, CIN
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | taking atorvastatin like placebo 12 hours before the procedure |
| long term statin group | No intervention | taking atorvastatin for a long time before entering the study (their routine treatment) |
| preoperation statin group | Experimental | taking atorvastatin 12 hours before the procedure Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast induced nephropathy (CIN) incidence
CIN is determined as an increase in post-procedural serum creatinine of > 0.5 mg/dl or > 25% from baseline in the absence of any other causes
Measured: 48 hours after the procedure
Secondary outcomes (1)
serum creatinine (Cr) level
Measured: 48 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startJan 2012
- Primary completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, peyman bidram, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113540
- Sponsor's protocol ID
- Grant number: 392172
- Acronym
- CIN
- Status last verified
- Apr 2014
- First submitted
- 5 Apr 2014
- Last updated
- 14 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin and Prevention of Contrast Induced Nephropathy Following Coronary Angiography
- ClinicalTrials.gov ID
- NCT02113540
- Acronym / sponsor ID
- CIN / Grant number: 392172
- Conditions
- Contrast Induced Nephropathy
- Keywords
- coronary angiography, chronic stable angina, CIN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2014 (estimated)
- First posted
- 14 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.
As the effect of statin use before the angiography to prevent contrast induced nephropathy (CIN) is not well-known, the aim of the current study is to assess the effect of atorvastatin on prevention of CIN in patients undergoing coronary angiography.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | –taking atorvastatin like placebo 12 hours before the procedure |
| long term statin group | No intervention | –taking atorvastatin for a long time before entering the study (their routine treatment) |
| preoperation statin group | Experimental | Drug: Atorvastatintaking atorvastatin 12 hours before the procedure |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- having chronic stable angina who were referred for coronary angiography
- non-pregnant female subjects
- no history of diabetes mellitus
- no history of renal failure
- no history of single kidney
Key exclusion criteria (2 listed)
- glomerular filtration rate (GFR) <60
- cardiogenic shock
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 | preoperation statin group |
Primary outcome
Contrast induced nephropathy (CIN) incidence
Time frame: 48 hours after the procedure
CIN is determined as an increase in post-procedural serum creatinine of > 0.5 mg/dl or > 25% from baseline in the absence of any other causes
1 secondary outcome
serum creatinine (Cr) level
Time frame: 48 hours after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin 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 10 inclusion and 2 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 14 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast induced nephropathy (CIN) incidence (time frame: 48 hours after the procedure). 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 14 Apr 2014.