Statin study halted early: did high doses shield the brain during surgery?
NCT ID NCT02850081
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether taking high doses of statins for two weeks before carotid artery surgery could prevent memory and thinking problems after the operation. It included 31 adults with severe carotid artery narrowing. The study was stopped early, so the results are limited and not conclusive.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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31 people
The number who actually took part.
- Started
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Jun 2017
- Finished
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Mar 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years of age. 2. Patient is currently on atorvastatin or simvastatin or rosuvastatin or statin naïve (no statins in the last 30 days). 3. The patient has unilateral or bilateral carotid artery stenosis that is considered severe (carotid artery diameter reduction ≥ 70%) as defined by: 1. Peak systolic velocity of at least 230 cm/s plus at least one of these: 2. End diastolic velocity ≥ 100 cm/s OR 3. CTA showing ≥ 70% stenosis OR 4. MRA showing ≥ 70% stenosis 4. This stenosis has not caused any stroke, transient cerebral ischemia, or other relevant neurological symptoms in the past. 5. 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. 6. The patient has no known circumstance or condition likely to preclude 1 year follow-up or adherence to the study protocol. 7. The patient is independent in their Activities of Daily Living at baseline. 8. Patient has the ability to provide informed consent. Exclusion Criteria: 1. Patient has underlying disease other than atherosclerosis (i.e. autoimmune disease, known active malignancy). 2. Patient has documented dementia or screens out based on abnormal Baseline MoCA (≤25) and AD8 (≥2). 3. Patient's life expectancy is \< 12 months. 4. Patient has advanced renal failure (serum creatinine \> 2.5 mg/dL) 5. 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). 6. Patient has history of intolerance or allergic reaction to any statins (myotoxicity, hepatic dysfunction, rash, etc.) 7. Patient has received an investigational drug within 30 days. 8. Patient is pregnant or lactating. 9. 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Albany Medical College/The Vascular Group at Albany
Albany, New York, 12208-3479, United States
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Columbia University Medical Center
New York, New York, 10032, United States
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Cornell University Medical College (Weill)
New York, New York, 10065-4805, United States
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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New York University School of Medicine
New York, New York, 10016-6402, United States
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State University of New York at Buffalo
Buffalo, New York, 14260-7016, United States
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Valley Hospital
Ridgewood, New Jersey, 07450, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new CT scanner see carotid plaques better?
- Could an arthritis drug shield heart and kidneys in metabolic syndrome?
- Could a double-barrel cholesterol drug shrink artery plaque better than statins alone?
- Balloon catheter may shield the brain from debris during artery stenting
- Blood test may flag heart danger before carotid surgery