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Trial record 1 of 1 for:    NCT01186289
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Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01186289
Recruitment Status : Withdrawn (Principal Investigator decided not to pursue enrollment due to changes in standard of care.)
First Posted : August 23, 2010
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by:
Duke University

Tracking Information
First Submitted Date  ICMJE August 19, 2010
First Posted Date  ICMJE August 23, 2010
Last Update Posted Date October 14, 2015
Study Start Date  ICMJE October 2010
Estimated Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery
Official Title  ICMJE Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Neurocognitive Dysfunction
Intervention  ICMJE Drug: atorvastatin
high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively
Other Name: Lipitor
Study Arms  ICMJE
  • Experimental: atorvastatin
    high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively
    Intervention: Drug: atorvastatin
  • Placebo Comparator: placebo
    Intervention: Drug: atorvastatin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 24, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2010)
50
Estimated Study Completion Date  ICMJE October 2012
Estimated Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01186289
Other Study ID Numbers  ICMJE PRO00020165
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark Newman, M. D., Duke University Medical Center Department of Anesthesiology
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Mark F Newman, M.D. Duke University
PRS Account Duke University
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP