Clincosm LogoSign in Get a demo

Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery

Sponsor
Duke University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01186289
Collaborator
Pfizer (Industry)
0
Enrollment
1
Location
2
Arms
24
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
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
Study Start Date :
Oct 1, 2010
Anticipated Primary Completion Date :
Oct 1, 2011
Anticipated Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Lipitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Neurocognitive Dysfunction [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01186289
    Other Study ID Numbers:
    • PRO00020165
    First Posted:
    Aug 23, 2010
    Last Update Posted:
    Oct 14, 2015
    Last Verified:
    Feb 1, 2011
    Keywords provided by , ,
    Neurocognitive Dysfunction
    Additional relevant MeSH terms:
    Cognitive Dysfunction
    Atorvastatin

    Study Results

    No Results Posted as of Oct 14, 2015