drugset / Trial / NCT02850081
Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |