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Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery

This study has been withdrawn prior to enrollment.
(Principal Investigator decided not to pursue enrollment due to changes in standard of care.)
Information provided by:
Duke University Identifier:
First received: August 19, 2010
Last updated: October 11, 2015
Last verified: February 2011
The primary aim of our prospective, randomized, double-blind interventional clinical trial is to determine the effectiveness of high dose atorvastatin therapy to reduce post operative cognitive dysfunction (POCD) in patients undergoing cardiac valve surgery. We hypothesize that therapy with high dose atorvastatin will significantly reduce the incidence and/or severity of POCD.

Condition Intervention
Neurocognitive Dysfunction
Drug: atorvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Neurocognitive Dysfunction [ Time Frame: 6 weeks and 1 year post surgery ]
    The subject will under go a battery of neurological test at baseline, 6 weeks post surgery and at 1 year post surgery to assess neurocognitive status.

Enrollment: 0
Study Start Date: October 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: atorvastatin
high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively
Drug: atorvastatin
high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively
Other Name: Lipitor
Placebo Comparator: placebo Drug: atorvastatin
high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively
Other Name: Lipitor


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Fifty informed and consenting patients for cardiac valve surgery with CPB , greater than 50 years of age and under the care of one or more of the investigators or consultants will be prospectively enrolled over a one-year period (plus one-year for follow-up).

Exclusion Criteria:

  • Patients with a history of the following disease entities will be excluded:

    • symptomatic cerebrovascular disease with substantial residual deficit, alcohol abuse, psychiatric illness, renal failure (creatinine>2.0),
    • hepatic dysfunction (ALT or AST > 1.5 x ULN), history of allergy or myopathy with statin therapy, pregnant or breastfeeding women or other comorbidities that in the opinion of the investigator could limit patient participation. Exclusion criteria are designed to limit confounding and enhance differentiation of deficits related to surgery and or treatment.
    • Patients who are unable to read and thus unable to complete the neurocognitive testing will also be excluded.
    • Patients having concomitant carotid endarterectomy or other vascular surgery will also be excluded to provide a more homogeneous sample for comparison.
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Please refer to this study by its identifier: NCT01186289

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: Mark F Newman, M.D. Duke University
  More Information

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Responsible Party: Mark Newman, M. D., Duke University Medical Center Department of Anesthesiology Identifier: NCT01186289     History of Changes
Other Study ID Numbers: PRO00020165
Study First Received: August 19, 2010
Last Updated: October 11, 2015

Keywords provided by Duke University:
Neurocognitive Dysfunction

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on May 24, 2017