Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery
This study has been withdrawn prior to enrollment.
(Principal Investigator decided not to pursue enrollment due to changes in standard of care.)
Sponsor:
Duke University
Collaborator:
Pfizer
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT01186289
First received: August 19, 2010
Last updated: February 18, 2011
Last verified: February 2011
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Purpose
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 | Intervention |
|---|---|
|
Neurocognitive Dysfunction |
Drug: atorvastatin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science |
| Official Title: | Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- Neurocognitive Dysfunction [ Time Frame: 6 weeks and 1 year post surgery ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Lipitor
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186289
Locations
| United States, North Carolina | |
| 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 |
More Information
Publications:
Reitan RM. Validity of the trail making test as an indicator of organic brain damage. Percept Mot Skills. 1958;8:271-276.
Radloff LS. The CES-D Scale: A self-report depression scale for research in the general population. Applied Psycological Measures. Vol 1; 1977:385-401.
| Responsible Party: | Mark Newman, M. D., Duke University Medical Center Department of Anesthesiology |
| ClinicalTrials.gov Identifier: | NCT01186289 History of Changes |
| Other Study ID Numbers: | PRO00020165 |
| Study First Received: | August 19, 2010 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Neurocognitive Dysfunction |
Additional relevant MeSH terms:
|
Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013