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Completed

NCT Number: NCT02737319

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

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

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Key information

Conditions

Nephropathy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Dante Pazzanese de Cardiologia

São Paulo, 04012-909, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rosuvastatin

Drug

40 mg of rosuvastatin before angioplasty

Other names: Group 1

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Instituto Dante Pazzanese de Cardiologia

Registry information

Official study title

A Randomized Trial of Rosuvastatin in Elective Percutaneous Coronary Intervention to Prevent Contrast-induced (CLEAR-CIN).

Acronym: CLEAR-CIN

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 13, 2016
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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