STANCE

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