Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.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:
Collaborator:
Pfizer
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT01186289
First received: August 19, 2010
Last updated: July 24, 2014
Last verified: February 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Reitan RM. Validity of the trail making test as an indicator of organic brain damage. Percept Mot Skills. 1958;8:271-276.
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.
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.

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
Study First Received: August 19, 2010
Last Updated: July 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Neurocognitive Dysfunction

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014