Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes
Objective
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.
Study Arms
- No Intervention: Observational - Maximal Dose - ARM 1
- Experimental: Less Than Maximal Dose - ARM 2
- Experimental: Statin Naive - ARM 3
Eligibility
- Patient is currently on atorvastatin or simvastatin or rosuvastatin or statin naïve (no statins in the last 30 days).
- The patient has unilateral or bilateral carotid artery stenosis that is considered severe (carotid artery diameter reduction ≥ 70%) as defined by:
- This stenosis has not caused any stroke, transient cerebral ischemia, or other relevant neurological symptoms in the past.
- The patient's attending doctor(s) (PMD, cardiologist, vascular/neurosurgeon) AND the patient have decided to proceed with a CEA to treat the patient's severe carotid stenosis.
- The patient has no known circumstance or condition likely to preclude 1-year follow-up or adherence to the study protocol.
- The patient is independent in their Activities of Daily Living at baseline.
NCT ID
NCT02850081
