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.
Carotid endarterectomy (CEA) is a common surgery performed to reduce the risk of stroke in patients with carotid artery narrowing. Statins, a class of drugs usually used to lower blood cholesterol, may protect the brain after surgery. Specific statins have been shown to protect the brain after surgery when compared to others. eCD affects about 25% of patients undergoing CEA and about 15% of undergoing asymptomatic CEA. It is associated with marked elevations in tissue markers of cerebral injury and is associated with earlier post-CEA mortality. This clinically significant, but subtle, cerebral injury is 10 times more common than stroke and its mechanism appears to be similarly related to regional hypoperfusion and ischemia. It is imperative to determine in a prospective randomized trial whether alteration/increase of preoperative statin regimens leads to improved neurologic outcome and an even lower incidence of stroke and possibly greater survival. In order to optimally design and conduct such a trial it is critical to: 1) explore the safety and feasibility of altering statin regimen acutely (approximately 2 weeks) before CEA, and 2) clearly establish the neuroprotective outcome of an acute alteration in statin regimen. This would promote a better understanding of statin neuroprotection in humans and determine the statin treatment that affords the most neuroprotection in patients undergoing one of the most commonly performed procedures in the US.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
31
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)
A lipid-lowering agent and for prevention of events associated with cardiovascular disease. 10 mg or 80 mg capsules
A placebo pill will be used for patients that are to maintain their current dose of statins prior to their CEA.
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
Prevalence of eCD
Neurocognitive assessments ≥2SD worse than reference group in two or more cognitive domains or (b) ≥1.5SD worse than the reference group in all cognitive domains. Due to early study termination and limited sample size, the study was not adequately powered to support inferential statistical comparisons. Therefore, outcome data are presented descriptively without formal statistical testing.
Time frame: 30 Days: 1) Pre-op vs. Post-CEA Day 1 (12-25 hrs post-op) and 2) Pre-op vs. Post-CEA Day 30
Prevalence of Early Mortality
Data will be collected by follow up phone call. Due to early study termination and limited sample size, the study was not adequately powered to support inferential statistical comparisons. Therefore, outcome data are presented descriptively without formal statistical testing.
Time frame: 1 year
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