Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes

Who is this study for? Adult patients with carotid artery stenosis and stroke
What treatments are being studied? Atorvastatin
Status: Completed
Location: See all (7) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

• Patient has the ability to provide informed consent.

Locations
United States
New Jersey
Valley Hospital
Ridgewood
New York
Albany Medical College/The Vascular Group at Albany
Albany
State University of New York at Buffalo
Buffalo
Columbia University Medical Center
New York
Cornell University Medical College (Weill)
New York
Icahn School of Medicine at Mount Sinai
New York
New York University School of Medicine
New York
Time Frame
Start Date: 2017-06-01
Completion Date: 2022-02-23
Participants
Target number of participants: 31
Treatments
No_intervention: Observational - Maximal Dose - ARM 1
Patients on a pre-existing maximal dose of either Simvastatin (40mg) with/without currently taking amlodipine (Norvasc) and those on Simvastatin 20mg while currently on amlodipine; Atorvastatin (80mg), or Rosuvastatin (20mg) regimen will be observed for \~2 weeks before their CEA.
Experimental: Less Than Maximal Dose - ARM 2
Patients on a pre-existing statin regimen at a lower dose (less than maximal) of Simvastatin \<40mg without amlodipine and \<20mg with amlodipine; Atorvastatin (\<80mg) or Rosuvastatin (\<20mg) will be randomized to maintain their current dose plus placebo or be increased to the maximal dose of their current statin for \~2 weeks before their CEA.
Experimental: Statin Naive - ARM 3
Patients on no pre-existing statin regimen will be randomized to Atorvastatin 10 mg or Atorvastatin 80 mg for \~2 weeks before their CEA
Sponsors
Leads: Columbia University

This content was sourced from clinicaltrials.gov

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