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A Randomized Trial of Rosuvastatin in Elective Angioplasty to Prevent Contrast-induced Nephropathy (CLEAR-CIN). (CLEAR-CIN)

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ClinicalTrials.gov Identifier: NCT02737319
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
Instituto Dante Pazzanese de Cardiologia
Information provided by (Responsible Party):
Kleber Bomfim Araujo Martins, University of Sao Paulo

Brief Summary:
The investigators analyzed the HMG-CoA reductase inhibitor, rosuvastatin, for the prevention of contrast-medium-induced nephropathy in patients undergoing primary angioplasty.

Condition or disease Intervention/treatment Phase
Nephropathy Drug: Rosuvastatin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 493 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Rosuvastatin in Elective Percutaneous Coronary Intervention to Prevent Contrast-induced (CLEAR-CIN).
Study Start Date : March 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rosuvastatin
40 mg of Rosuvastatin up to 6 hours before elective percutaneous coronary intervention.
Drug: Rosuvastatin
40 mg of rosuvastatin before angioplasty
Other Name: Group 1

No Intervention: Control
Use of standard therapy in elective angioplasty.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Composite end-point ( all cause of death; acute renal failure and no-fatal mayocardial infarctio. [ Time Frame: 48 hours ]
    Death, myocardial infarction or kidney insufficiency



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737319


Locations
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Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil, 04012-909
Sponsors and Collaborators
University of Sao Paulo
Instituto Dante Pazzanese de Cardiologia
Investigators
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Principal Investigator: Kleber Bomfim A Martins, MD, PhD Instituto Date Pazzanese de Cardiologia

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Responsible Party: Kleber Bomfim Araujo Martins, MD,PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02737319     History of Changes
Other Study ID Numbers: IDPC3851
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kleber Bomfim Araujo Martins, University of Sao Paulo:
Contrast,nephropathy, angioplasty, stable coronary
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors