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

Phase 4

Completed

• Conditions: Nephropathy
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT02737319
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-03
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-04
• Study First Submitted: 2016-04-08
• Study First Submitted QC: 2016-04-08
• Last Update Submitted: 2016-04-12
• Study First Posted: 2016-04-13
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 493

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Rosuvastatin	40 mg of Rosuvastatin up to 6 hours before elective percutaneous coronary intervention.

Primary Outcome Measures

Name	Time	Method
Contrast induce nephropathy defined by serum creatinine increase more than 0.3mg/dl or 50% higher than baseline	48 hours	Serum creatinine increase more than 0.3mg/dl or 50% higher than baseline

Secondary Outcome Measures

Name	Time	Method
Composite end-point ( all cause of death; acute renal failure and no-fatal mayocardial infarctio.	48 hours	Death, myocardial infarction or kidney insufficiency

Trial Locations

Locations (1)

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 São Paulo, Brazil