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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

493 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Rosuvastatin

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

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

40 mg of rosuvastatin before angioplasty

Control

Use of standard therapy in elective angioplasty.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rosuvastatin

40 mg of rosuvastatin before angioplasty

Intervention Type DRUG

Other Intervention Names

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Group 1

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes