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TERMINATED
NCT02850081
PHASE3

Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes

Sponsor: Columbia University

View on ClinicalTrials.gov

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

Interventions

DRUG

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)

DRUG

Atorvastatin

A lipid-lowering agent and for prevention of events associated with cardiovascular disease. 10 mg or 80 mg capsules

OTHER

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