A Randomized Trial of Rosuvastatin in Elective Angioplasty to Prevent Contrast-induced Nephropathy (CLEAR-CIN). (CLEAR-CIN)
Primary Purpose
Nephropathy
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
About this trial
This is an interventional prevention trial for Nephropathy focused on measuring Contrast,nephropathy, angioplasty, stable coronary
Eligibility Criteria
Inclusion Criteria:
- chronic statin use
- positive stress test findings (electrocardiography, nuclear imaging, or stress echocardiography
- elective angioplasty.
Exclusion Criteria:
- 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).
Sites / Locations
- Instituto Dante Pazzanese de Cardiologia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rosuvastatin
Control
Arm Description
40 mg of Rosuvastatin up to 6 hours before elective percutaneous coronary intervention.
Use of standard therapy in elective angioplasty.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Composite end-point ( all cause of death; acute renal failure and no-fatal mayocardial infarctio.
Death, myocardial infarction or kidney insufficiency
Full Information
NCT ID
NCT02737319
First Posted
April 8, 2016
Last Updated
April 12, 2016
Sponsor
University of Sao Paulo
Collaborators
Instituto Dante Pazzanese de Cardiologia
1. Study Identification
Unique Protocol Identification Number
NCT02737319
Brief Title
A Randomized Trial of Rosuvastatin in Elective Angioplasty to Prevent Contrast-induced Nephropathy (CLEAR-CIN).
Acronym
CLEAR-CIN
Official Title
A Randomized Trial of Rosuvastatin in Elective Percutaneous Coronary Intervention to Prevent Contrast-induced (CLEAR-CIN).
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Instituto Dante Pazzanese de Cardiologia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephropathy
Keywords
Contrast,nephropathy, angioplasty, stable coronary
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
493 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin
Arm Type
Experimental
Arm Description
40 mg of Rosuvastatin up to 6 hours before elective percutaneous coronary intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Use of standard therapy in elective angioplasty.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Group 1
Intervention Description
40 mg of rosuvastatin before angioplasty
Primary Outcome Measure Information:
Title
Contrast induce nephropathy defined by serum creatinine increase more than 0.3mg/dl or 50% higher than baseline
Description
Serum creatinine increase more than 0.3mg/dl or 50% higher than baseline
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Composite end-point ( all cause of death; acute renal failure and no-fatal mayocardial infarctio.
Description
Death, myocardial infarction or kidney insufficiency
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
chronic statin use
positive stress test findings (electrocardiography, nuclear imaging, or stress echocardiography
elective angioplasty.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kleber Bomfim A Martins, MD, PhD
Organizational Affiliation
Instituto Date Pazzanese de Cardiologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
São Paulo
ZIP/Postal Code
04012-909
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized Trial of Rosuvastatin in Elective Angioplasty to Prevent Contrast-induced Nephropathy (CLEAR-CIN).
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