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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This study has been withdrawn prior to enrollment.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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01186289
First Posted: August 23, 2010
Last Update Posted: October 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by:
Duke University
  Purpose
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: Triple (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

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186289


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

Publications:
Rey A. L'examen clinique en psychologie. Paris: Presses Universitaires de France;1964
Wechsler D. The Wechsler Adult Intelligence Scale-Revised (WAIS-R). San Antonio, Texas: The Psychological Corporation; 1981
Reitan RM. Validity of the trail making test as an indicator of organic brain damage. Percept Mot Skills. 1958;8:271-276.
Benton AL, Hansher K. Multilingual Aphasia Examination. Iowa City: University of Iowa Press; 1978
Fillenbaum GG. Multidimensional functional assessment of older adults (The Duke Older Americans Resources and Services Procedures). Hillsdale, N.J.: Erlbaum Associates; 1988
Ware JE, Snow KK, Kosinski M, et al. SF-36 Health Survey: Manual and Interpretation Guide. Lincon, Rhode Island: Qualitymetric, Inc.;2000
Ware JE, Kosinski KK, Keller SD. SF-36 Physical and Mental Health Summary Scales: A User's Manual. Boston: Health Assessment Lab, New England Medical Center; 1994
Axelrad KJ. Locus of Control and Casual Attributions As they Relate to Expectations for Coping With A Heart Attack. Los Angeles, California School of Professional Psychology; 1981.
Radloff LS. The CES-D Scale: A self-report depression scale for research in the general population. Applied Psycological Measures. Vol 1; 1977:385-401.
Spielberger C, Gorsuch R, Lushene R. STAI Manual Palo Alto: Consulting Psychologists Press, Inc; 1970
McNair DM, Kahn RJ. Self-assessment of Cognitive Deficits. In: Crook T., Ferris, S.,Bartus, R., ed. Assessment In Geriatric Psychopharmacology. New Canaan, Ct.: Mark Powley Associates, Inc.: 1983.
Cronbach LJ. Essentials of Psychological Testing. New York: Harper and Row; 1970

Responsible Party: Mark Newman, M. D., Duke University Medical Center Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT01186289     History of Changes
Other Study ID Numbers: PRO00020165
First Submitted: August 19, 2010
First Posted: August 23, 2010
Last Update Posted: October 14, 2015
Last Verified: February 2011

Keywords provided by Duke University:
Neurocognitive Dysfunction

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors