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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02737319

Acronym

CLEAR-CIN

Enrollment

493

Registered

2016-04-13

Start date

2011-03-31

Completion date

2013-12-31

Last updated

2016-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephropathy

Keywords

Contrast,nephropathy, angioplasty, stable coronary

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.

Interventions

DRUGRosuvastatin

40 mg of rosuvastatin before angioplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026