NephropathyPhase 4CLEAR-CINNCT02737319
A Randomized Trial of Rosuvastatin in Elective Angioplasty to Prevent Contrast-induced Nephropathy (CLEAR-CIN).
A Phase 4 study testing Rosuvastatin in people with Nephropathy, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The investigators analyzed the HMG-CoA reductase inhibitor, rosuvastatin, for the prevention of contrast-medium-induced nephropathy in patients undergoing primary angioplasty. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nephropathy
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 493 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Dec 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- chronic statin use
- positive stress test findings (electrocardiography, nuclear imaging, or stress echocardiography
- elective angioplasty.
Who cannot join
- non-statin therapy
- any presentation of ACS within 24 hours before the time of randomization
- current use of potent CYP3A4 inhibitors, including azole antifungals, protease inhibitors, macrolide antibiotics, and cyclosporine
- renal replacement therapy, a history of kidney transplant, pregnant and with renal failure (serum creatinine > 3.0 mg/dl).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-909
About this study
Official title: A Randomized Trial of Rosuvastatin in Elective Percutaneous Coronary Intervention to Prevent Contrast-induced (CLEAR-CIN).
The investigators analyzed the HMG-CoA reductase inhibitor, rosuvastatin, for the prevention of contrast-medium-induced nephropathy in patients undergoing primary angioplasty.
Read the detailed description
Patients with stable coronary artery disease already taking chronic statin undergoing elective angioplasty are at risk for contrast-medium-induced nephropathy because there are specified risk factors as age more than 75 years, chronic renal insufficiency, diabetes, use of contrast and the lack of effective prophylaxis.
- Conditions
- Nephropathy
- Being tested
- Rosuvastatin
- Keywords
- Contrast,nephropathy, angioplasty, stable coronary
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Group 1
40 mg of rosuvastatin before angioplasty
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | 40 mg of Rosuvastatin up to 6 hours before elective percutaneous coronary intervention. Receives: Drug: Rosuvastatin |
| Control | No intervention | Use of standard therapy in elective angioplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast induce nephropathy defined by serum creatinine increase more than 0.3mg/dl or 50% higher than baseline
Serum creatinine increase more than 0.3mg/dl or 50% higher than baseline
Measured: 48 hours
Secondary outcomes (1)
Composite end-point ( all cause of death; acute renal failure and no-fatal mayocardial infarctio.
Death, myocardial infarction or kidney insufficiency
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 posted13 Apr 2016 (estimated)
- Study startMar 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephropathyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Dante Pazzanese de Cardiologia
- Responsible party
- Principal investigator, Kleber Bomfim Araujo Martins, University of Sao Paulo
- Investigators
- Kleber Bomfim A Martins, MD, PhD, Principal investigator, Instituto Date Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737319
- Sponsor's protocol ID
- IDPC3851
- Acronym
- CLEAR-CIN
- Status last verified
- Apr 2016
- First submitted
- 8 Apr 2016
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Rosuvastatin in Elective Percutaneous Coronary Intervention to Prevent Contrast-induced (CLEAR-CIN).
- ClinicalTrials.gov ID
- NCT02737319
- Acronym / sponsor ID
- CLEAR-CIN / IDPC3851
- Conditions
- Nephropathy
- Keywords
- Contrast,nephropathy, angioplasty, stable coronary
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Instituto Dante Pazzanese de Cardiologia
- Study start
- Mar 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Apr 2016 (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 investigators analyzed the HMG-CoA reductase inhibitor, rosuvastatin, for the prevention of contrast-medium-induced nephropathy in patients undergoing primary angioplasty.
Detailed description
Patients with stable coronary artery disease already taking chronic statin undergoing elective angioplasty are at risk for contrast-medium-induced nephropathy because there are specified risk factors as age more than 75 years, chronic renal insufficiency, diabetes, use of contrast and the lack of effective prophylaxis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Rosuvastatin40 mg of Rosuvastatin up to 6 hours before elective percutaneous coronary intervention. |
| Control | No intervention | –Use of standard therapy in elective angioplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic statin use
- positive stress test findings (electrocardiography, nuclear imaging, or stress echocardiography
- elective angioplasty.
Key exclusion criteria (4 listed)
- non-statin therapy
- any presentation of ACS within 24 hours before the time of randomization
- current use of potent CYP3A4 inhibitors, including azole antifungals, protease inhibitors, macrolide antibiotics, and cyclosporine
- renal replacement therapy, a history of kidney transplant, pregnant and with renal failure (serum creatinine > 3.0 mg/dl).
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 |
|---|---|---|
| RosuvastatinAlso: Group 140 mg of rosuvastatin before angioplasty | Drug | Rosuvastatin |
Primary outcome
Contrast induce nephropathy defined by serum creatinine increase more than 0.3mg/dl or 50% higher than baseline
Time frame: 48 hours
Serum creatinine increase more than 0.3mg/dl or 50% higher than baseline
1 secondary outcome
Composite end-point ( all cause of death; acute renal failure and no-fatal mayocardial infarctio.
Time frame: 48 hours
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 14 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Kleber Bomfim A Martins, MD, PhD principal investigator
Instituto Date Pazzanese de Cardiologia
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 Rosuvastatin in people with Nephropathy, run by University of Sao Paulo at 1 site in Brazil.
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 4 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 14 Apr 2016. 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 Brazil. 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. 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?
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?
Contrast induce nephropathy defined by serum creatinine increase more than 0.3mg/dl or 50% higher than baseline (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 14 Apr 2016.