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Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes
Sponsor: Columbia University
Summary
The investigators hypothesize that pre-operative statin use is neuroprotective at maximal doses. The goals are to determine the safety, feasibility, and efficacy of maximizing statin doses for two weeks (12-18 days) prior to CEA using change in performance on a battery neuropsychometric tests as outcome measure. Study will recruit patients based on their preexisting statin regimen. The investigators hypothesize that in asymptomatic CEA patients: 1) Pre-operative statin use is neuroprotective against early cognitive dysfunction (eCD) and lowers the risk of early mortality. 2) Maximal doses may be essential in achieving optimal neuroprotection against eCD.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2017-06-01
Completion Date
2020-03-31
Last Updated
2026-05-07
Healthy Volunteers
No
Conditions
Interventions
Statin
Standard of care treatment (one of four): * Simvastatin (to 40mg without amlodipine) * Simvastatin (to 20 mg if currently on amlodipine) * Atorvastatin (to 80mg) * Rosuvastatin (to 20mg)
Atorvastatin
A lipid-lowering agent and for prevention of events associated with cardiovascular disease. 10 mg or 80 mg capsules
Placebo
A placebo pill will be used for patients that are to maintain their current dose of statins prior to their CEA.
Locations (7)
Valley Hospital
Ridgewood, New Jersey, United States
Albany Medical College/The Vascular Group at Albany
Albany, New York, United States
State University of New York at Buffalo
Buffalo, New York, United States
New York University School of Medicine
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Cornell University Medical College (Weill)
New York, New York, United States