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Efficacy of Statins In Prevention of CIN

NCT ID: NCT01071993

Last Updated: 2017-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-07-31

Brief Summary

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To determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.

Detailed Description

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Due to the conflict in the available data, there are no practice guidelines that are established in order to prevent contrast-induced nephropathy (CIN). Our goal is to determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.

Conditions

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Nephropathy

Keywords

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prevention nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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atorvastatin

Group Type ACTIVE_COMPARATOR

atorvastatin

Intervention Type DRUG

pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)

Interventions

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placebo

pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)

Intervention Type DRUG

atorvastatin

pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults \> 18 years of age
* undergoing coronary or peripheral angiography with or without intervention
* Cr \> 1.3 mg/dL or GFR \< 60 mL/min

Exclusion Criteria

* end-stage renal disease on dialysis
* acute renal failure
* previous iodinated contrast media exposure within 7 days of study entry
* history of hypersensitivity to statins
* pregnancy or lactation
* emergent coronary angiography, ST elevation myocardial infarction (STEMI), or cardiogenic shock
* prisoners
* patients already on maximum dose of statins
* patient receiving N-acetylcysteine or sodium bicarbonate
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mazen Abu-Fadel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oklahoma Univeristy Health Science Center and VA Medical Center

Locations

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Oklahoma University Health Science Center

Oklahoma City, Oklahoma, United States

Site Status

Veterans Affairs Medical Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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15097

Identifier Type: -

Identifier Source: org_study_id