Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes (NCT02850081) | Clinical Trial Compass
TerminatedPhase 3
Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes
Stopped: The study was terminated early due to recruitment limitations, particularly difficulty enrolling statin-naïve patients
United States31 participantsStarted 2017-06-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years of age.
✓. 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:
✓. Peak systolic velocity of at least 230 cm/s plus at least one of these:
✓. End diastolic velocity ≥ 100 cm/s OR
✓. CTA showing ≥ 70% stenosis OR
✓. MRA showing ≥ 70% stenosis
✓. This stenosis has not caused any stroke, transient cerebral ischemia, or other relevant neurological symptoms in the past.
Exclusion criteria
✕. Patient has underlying disease other than atherosclerosis (i.e. autoimmune disease, known active malignancy).
✕
What they're measuring
1
Prevalence of eCD
Timeframe: 30 Days: 1) Pre-op vs. Post-CEA Day 1 (12-25 hrs post-op) and 2) Pre-op vs. Post-CEA Day 30
✕. Patient has evidence of severe congestive heart failure or has history of end-stage cardiovascular disease (e.g. CHF NYHA Class III or IV or unstable angina).
✕. Patient has history of intolerance or allergic reaction to any statins (myotoxicity, hepatic dysfunction, rash, etc.)
✕. Patient has received an investigational drug within 30 days.