A Randomized Trial of Rosuvastatin in Elective Angioplasty to Prevent Contrast-induced Nephropathy (CLEAR-CIN).
CLEAR-CIN
1 other identifier
interventional
493
1 country
1
Brief Summary
The investigators analyzed the HMG-CoA reductase inhibitor, rosuvastatin, for the prevention of contrast-medium-induced nephropathy in patients undergoing primary angioplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 8, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2016
CompletedApril 14, 2016
April 1, 2016
2.8 years
April 8, 2016
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
48 hours
Secondary Outcomes (1)
Composite end-point ( all cause of death; acute renal failure and no-fatal mayocardial infarctio.
48 hours
Study Arms (2)
Rosuvastatin
EXPERIMENTAL40 mg of Rosuvastatin up to 6 hours before elective percutaneous coronary intervention.
Control
NO INTERVENTIONUse of standard therapy in elective angioplasty.
Interventions
Eligibility Criteria
You may qualify if:
- chronic statin use
- positive stress test findings (electrocardiography, nuclear imaging, or stress echocardiography
- elective angioplasty.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulolead
- Instituto Dante Pazzanese de Cardiologiacollaborator
Study Sites (1)
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-909, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kleber Bomfim A Martins, MD, PhD
Instituto Date Pazzanese de Cardiologia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,PhD
Study Record Dates
First Submitted
April 8, 2016
First Posted
April 13, 2016
Study Start
March 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 14, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share