drugset / Trial / NCT02850081

Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes

NCT02850081 ↗

Phase 3 Terminated 31 enrolled Columbia University
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2017-06-01
Primary completion
2020-03-31
Completion
2020-03-31

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated early due to recruitment limitations, particularly difficulty enrolling statin-naïve patients”

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 10 mg —
Subject Atorvastatin Small molecule 80 mg —
Subject Rosuvastatin Small molecule 20 mg —
Subject Simvastatin Small molecule 20 mg —
Subject Simvastatin Small molecule 40 mg —