Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery

NCT01186289 | Withdrawn DMC

• 1 other identifier: PRO00020165
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurocognitive Dysfunction

Keywords

Neurocognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks and 1 year post surgery

Study Arms (2)

atorvastatin

EXPERIMENTAL

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

Drug: atorvastatin

placebo

PLACEBO COMPARATOR

Drug: atorvastatin

Interventions

atorvastatin DRUG

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

Also known as: Lipitor

atorvastatin; placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Pfizer: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

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MeSH Terms

Conditions

Cognition Disorders

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Mark F Newman, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2012
• Last Updated: October 14, 2015

Record last verified: 2011-02

Locations

US (1)