Carotid Artery StenosisPhase 3STANCENCT02850081
Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes
A Phase 3 study testing Statin and Atorvastatin in people with Carotid Artery Stenosis and Strokes, run by Columbia University at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis, Strokes
- What is being tested?
- Statin and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Jun 2017to 31 Mar 2020
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Patient has underlying disease other than atherosclerosis (i.e. autoimmune disease, known active malignancy).
- Patient has documented dementia or screens out based on abnormal Baseline MoCA (≤25) and AD8 (≥2).
- Patient's life expectancy is < 12 months.
- Patient has advanced renal failure (serum creatinine > 2.5 mg/dL)
- 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.)
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- Patient has received an investigational drug within 30 days.
- Patient is pregnant or lactating.
- Patient is currently taking any of the following which have been shown to interact with atorvastatin and/or simvastatin and/or rosuvastatin (as per current drug package inserts):
- Cyclosporine;
- HIV Protease Inhibitors/Antivirals (e.g. rotanavir or plus rotanavir, tipranavir, lopinavir, boceprevir, saquinovir, darunavir, fosamprenavir, nelfinavir, efavirenz/tenofobir, atazanavir, simeprevir);
- Hep C Protease Inhibitor/Antivirals (e.g. telapravir);
- Antibiotics (i.e. cobicistat-containing products like Tybost, rifampin/rifampicin, clarithromycin, telithromycin, erythromycin);
- Anti-fungals (i.e. itraconazole, ketoconazole, posaconazole, voriconazole, fluconazole); *Gemfibrozil; Other Fenofibrates (e.g. Tricor, fibric acid);
- Niacin > 1g/day or statins in combination with niacin (e.g. Vytorin, Simcor);
- Colchicine;
- Danazol;
- Calcium Channel Blockers: Diltiazem, Varapamil;
- Dronedarone;
- Amiodarone;
- Digoxin;
- Ranolazine;
- Nefazodone;
- Warfarin/Coumadin;
- Lomitapide;
- Grapefruit juice > 1.2 liters/day (40.5 ounces/day).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Albany Medical College/The Vascular Group at Albany
Albany, New York, 12208-3479
State University of New York at Buffalo
Buffalo, New York, 14260-7016
New York University School of Medicine
New York, New York, 10016-6402
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Cornell University Medical College (Weill)
New York, New York, 10065-4805
Valley Hospital
Ridgewood, New Jersey, 07450
About this study
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.
Read the detailed description
Carotid endarterectomy (CEA) is a common surgery performed to reduce the risk of stroke in patients with carotid artery narrowing. Statins, a class of drugs usually used to lower blood cholesterol, may protect the brain after surgery. Specific statins have been shown to protect the brain after surgery when compared to others. eCD affects about 25% of patients undergoing CEA and about 15% of undergoing asymptomatic CEA. It is associated with marked elevations in tissue markers of cerebral injury and is associated with earlier post-CEA mortality. This clinically significant, but subtle, cerebral injury is 10 times more common than stroke and its mechanism appears to be similarly related to regional hypoperfusion and ischemia. It is imperative to determine in a prospective randomized trial whether alteration/increase of preoperative statin regimens leads to improved neurologic outcome and an even lower incidence of stroke and possibly greater survival.
In order to optimally design and conduct such a trial it is critical 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. This would promote a better understanding of statin neuroprotection in humans and determine the statin treatment that affords the most neuroprotection in patients undergoing one of the most commonly performed procedures in the US.
- Conditions
- Carotid Artery Stenosis, Strokes
- Being tested
- Statin, Atorvastatin, Placebo
- Keywords
- Carotid endarterectomy, CEA, stroke, asymptomatic stenosis
- Medical subject headings
- Carotid Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
Also called Pre-existing statin regimen
Standard of care treatment (one of four):
- Simvastatin (to 40mg without amlodipine)
- Simvastatin (to 20 mg if currently on amlodipine)
- Atorvastatin (to 80mg)
- Rosuvastatin (to 20mg)
AtorvastatinDrug
Also called Lipitor
A lipid-lowering agent and for prevention of events associated with cardiovascular disease.
10 mg or 80 mg capsules
PlaceboOther
Also called Sugar pill
A placebo pill will be used for patients that are to maintain their current dose of statins prior to their CEA.
| Study group | Role | What they receive |
|---|---|---|
| Observational - Maximal Dose - ARM 1 | No intervention | 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. |
| Less Than Maximal Dose - ARM 2 | Experimental | 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. Receives: Drug: Statin; Other: Placebo |
| Statin Naive - ARM 3 | Experimental | Patients on no pre-existing statin regimen will be randomized to Atorvastatin 10 mg or Atorvastatin 80 mg for ~2 weeks before their CEA Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of eCD
Neurocognitive assessments ≥2SD worse than reference group in two or more cognitive domains or (b) ≥1.5SD worse than the reference group in all cognitive domains.
Due to early study termination and limited sample size, the study was not adequately powered to support inferential statistical comparisons. Therefore, outcome data are presented descriptively without formal statistical testing.
Measured: 30 Days: 1) Pre-op vs. Post-CEA Day 1 (12-25 hrs post-op) and 2) Pre-op vs. Post-CEA Day 30
Secondary outcomes (1)
Prevalence of Early Mortality
Data will be collected by follow up phone call.
Due to early study termination and limited sample size, the study was not adequately powered to support inferential statistical comparisons. Therefore, outcome data are presented descriptively without formal statistical testing.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start1 Jun 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Why it stopped: The study was terminated early due to recruitment limitations, particularly difficulty enrolling statin-naïve patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E. Sander Connolly, Columbia University
- Investigators
- Edward S Connolly, MD, FACS, Principal investigator, Columbia University Medical Center/New York PresbyterianEric Heyer, MD, Ph.D., Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850081
- Sponsor's protocol ID
- AAAM2407
- Acronym
- STANCE
- Status last verified
- Apr 2026
- First submitted
- 27 Jul 2016
- Last updated
- 7 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No