Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes (STANCE)
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|ClinicalTrials.gov Identifier: NCT02850081|
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : June 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Stenosis Strokes||Drug: Statin Drug: Atorvastatin Other: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||April 2022|
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.
Standard of care treatment (one of four):
Other Name: Pre-existing statin regimen
A placebo pill will be used for patients that are to maintain their current dose of statins prior to their CEA.
Other Name: Sugar pill
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
A lipid-lowering agent and for prevention of events associated with cardiovascular disease.
10 mg or 80 mg capsules
Other Name: Lipitor
- Prevalence of eCD [ Time Frame: 30 Days: 1) Pre-op vs. Post-CEA Day 1 (12-25 hrs post-op) and 2) Pre-op vs. Post-CEA Day 30 ]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.
- Prevalence of early mortality [ Time Frame: 1 year ]Data will be collected by follow up phone call
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850081
|Contact: Rebeca Aragon Garcia, BSfirstname.lastname@example.org|
|Contact: Josephine U Pucci, BAemail@example.com|
|United States, New Jersey|
|Valley Hospital||Not yet recruiting|
|Ridgewood, New Jersey, United States, 07450|
|Contact: Avery Freed 201-389-0194 firstname.lastname@example.org|
|Contact: Kathleen Sayles KSAYLES@valleyhealth.com|
|Principal Investigator: Dorothea Altschul, MD|
|United States, New York|
|Albany Medical College/The Vascular Group at Albany||Not yet recruiting|
|Albany, New York, United States, 12208-3479|
|Contact: Ryan Kaim KaimR@mail.amc.edu|
|Contact: Angela Sheehan SheehaA@mail.amc.edu|
|Principal Investigator: Courtney Warner, MD|
|Sub-Investigator: Ralph C Darling, MD|
|State University of New York at Buffalo||Not yet recruiting|
|Buffalo, New York, United States, 14260-7016|
|Contact: Jennifer Gay 716-440-4231 email@example.com|
|Contact: Reagan O'Toole firstname.lastname@example.org|
|Principal Investigator: Adnan Siddiqui, MD|
|New York University School of Medicine||Not yet recruiting|
|New York, New York, United States, 10016-6402|
|Contact: Jacqueline Bott 212-263-2268 email@example.com|
|Principal Investigator: Thomas Maldonado, MD|
|Icahn School of Medicine at Mount Sinai||Not yet recruiting|
|New York, New York, United States, 10029|
|Contact: Rebecca Apruzzese 212-241-8349 firstname.lastname@example.org|
|Contact: Milerva Santos email@example.com|
|Principal Investigator: J Mocco, MD|
|Sub-Investigator: Emilia Bagiella, MD|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Rebeca Aragon Garcia, BS 212-305-4679 firstname.lastname@example.org|
|Contact: Josephine U Pucci, BA 21123054679 email@example.com|
|Principal Investigator: Edward S Connolly, MD|
|Sub-Investigator: Elise A Caccappolo Van Vliet, PhD|
|Sub-Investigator: Yaakov Stern, MD|
|Sub-Investigator: Richard Buchsbaum|
|Sub-Investigator: Eric J Heyer, MD|
|Sub-Investigator: Erin L Heinzen-Cox, PhD|
|Cornell University Medical College (Weill)||Not yet recruiting|
|New York, New York, United States, 10065-4805|
|Contact: Ruchita Mehta firstname.lastname@example.org|
|Principal Investigator: Peter Connolly, MD|
|Principal Investigator:||Edward S Connolly, MD, FACS||Columbia University Medical Center/New York Presbyterian|
|Study Director:||Eric Heyer, MD, Ph.D.||Columbia University|