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Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes

NCT02850081 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-05-07

Study results available
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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.

Conditions

Interventions

OTHER

Placebo

A placebo pill will be used for patients that are to maintain their current dose of statins prior to their CEA.

DRUG

Atorvastatin

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

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)

Sponsors & Collaborators

Principal Investigators

  • Edward S Connolly, MD, FACS · Columbia University Medical Center/New York Presbyterian

  • Eric Heyer, MD, Ph.D. · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2020-03-31
Completion
2020-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02850081 on ClinicalTrials.gov