Efficacy of Statins In Prevention of CIN

NCT01071993 | Terminated Results DMC

• 1 other identifier: 15097
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

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

Nephropathy

Keywords

prevention; nephropathy

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours.

  Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of \> 0.5 mg/dL or \>25% Increase From Baseline at 24 \& at 48 Hours

  48 hours

Study Arms (2)

atorvastatin

ACTIVE COMPARATOR

Drug: atorvastatin

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

placebo DRUG

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

placebo

atorvastatin DRUG

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

atorvastatin

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (2)

Oklahoma University Health Science Center

Oklahoma City, Oklahoma, 73104, United States

Location

Veterans Affairs Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Limitations and Caveats

Study Sponsor no longer supplied study drug/placebo.

Results Point of Contact

• Title: Mazen Abu-Fadel, MD
• Organization: University of Oklahoma

mazen-abufadel@ouhsc.edu

405-271-4742

Study Officials

• Mazen Abu-Fadel, M.D.

  Oklahoma Univeristy Health Science Center and VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 4, 2017
• Results First Posted: September 13, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)