Status:
WITHDRAWN
Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery
Lead Sponsor:
Duke University
Collaborating Sponsors:
Pfizer
Conditions:
Neurocognitive Dysfunction
Eligibility:
All Genders
50+ years
Phase:
NA
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 dysfun...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01186289
Start Date
October 1 2010
End Date
October 1 2012
Last Update
October 14 2015
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710