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Statin study halted early: did high doses shield the brain during surgery?

NCT ID NCT02850081

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

31 people

The number who actually took part.

Started

Jun 2017

Finished

Mar 2020

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Albany Medical College/The Vascular Group at Albany

    Albany, New York, 12208-3479, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Cornell University Medical College (Weill)

    New York, New York, 10065-4805, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • New York University School of Medicine

    New York, New York, 10016-6402, United States

  • State University of New York at Buffalo

    Buffalo, New York, 14260-7016, United States

  • Valley Hospital

    Ridgewood, New Jersey, 07450, United States

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Other studies related to the condition(s) this trial covers.