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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01186289
Other study ID # PRO00020165
Secondary ID
Status Withdrawn
Phase N/A
First received August 19, 2010
Last updated October 11, 2015
Start date October 2010
Est. completion date October 2012

Study information

Verified date February 2011
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Duke University Pfizer

Country where clinical trial is conducted

United States, 

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* Note: There are 64 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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