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Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery

Primary Purpose

Neurocognitive Dysfunction

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
atorvastatin
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neurocognitive Dysfunction focused on measuring Neurocognitive Dysfunction

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

atorvastatin

placebo

Arm Description

high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively

Outcomes

Primary Outcome Measures

Neurocognitive Dysfunction
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.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2010
Last Updated
October 11, 2015
Sponsor
Duke University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01186289
Brief Title
Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery
Official Title
Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Principal Investigator decided not to pursue enrollment due to changes in standard of care.
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Duke University
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocognitive Dysfunction
Keywords
Neurocognitive Dysfunction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
atorvastatin
Arm Type
Experimental
Arm Description
high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively
Primary Outcome Measure Information:
Title
Neurocognitive Dysfunction
Description
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.
Time Frame
6 weeks and 1 year post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark F Newman, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery

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