Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery
NCT ID: NCT01186289
Last Updated: 2015-10-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
NA
Study Classification
INTERVENTIONAL
Study Start Date
2010-10-31
Study Completion Date
2012-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Neurocognitive Dysfunction
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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atorvastatin
high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively
Group Type
EXPERIMENTAL
atorvastatin
Intervention Type
DRUG
high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively
placebo
Group Type
PLACEBO_COMPARATOR
atorvastatin
Intervention Type
DRUG
high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively
Interventions
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atorvastatin
high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively
Intervention Type
DRUG
Other Intervention Names
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Lipitor
Eligibility Criteria
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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),
* 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.
* symptomatic cerebrovascular disease with substantial residual deficit, alcohol abuse, psychiatric illness, renal failure (creatinine\>2.0),
* 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.
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Pfizer
INDUSTRY
Sponsor Role
collaborator
Duke University
OTHER
Sponsor Role
lead
Responsible Party
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Duke University Medical Center Department of Anesthesiology
Principal Investigators
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Mark F Newman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Site Status
Countries
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United States
References
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Other Identifiers
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PRO00020165
Identifier Type: -
Identifier Source: org_study_id
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