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

University of Sao Paulo

Status and phase

Completed

Phase 4

Conditions

Nephropathy

Treatments

Drug: Rosuvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT02737319

IDPC3851

Details and patient eligibility

About

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

Full 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.

Enrollment

493 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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).