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

University of Sao Paulo493 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

493

Conditions

Nephropathy

Interventions

RosuvastatinDRUG

40 mg of rosuvastatin before angioplasty

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

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

Time frame: 48 hours

Secondary Outcomes

Composite end-point ( all cause of death; acute renal failure and no-fatal mayocardial infarctio.

Death, myocardial infarction or kidney insufficiency

Time frame: 48 hours

Data from ClinicalTrials.gov

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