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HMG-CoA Reductase Inhibitor

Statin for Stroke (STANCE Trial)

Phase 3
Waitlist Available
Led By Edward S Connolly, MD, FACS
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

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.

Eligible Conditions
  • Stroke
  • Carotid Artery Stenosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prevalence of eCD
Secondary outcome measures
Prevalence of early mortality

Side effects data

From 2015 Phase 3 trial • 803 Patients • NCT01926782
9%
Nasopharyngitis
9%
Injection site reaction
7%
Upper respiratory tract infection
6%
Nausea
6%
Urinary tract infection
6%
Arthralgia
6%
Bronchitis
5%
Headache
5%
Non-Cardiac chest pain
3%
Diarrhoea
3%
Back pain
3%
Muscle spasms
3%
Hypertension
3%
Sinusitis
2%
Pneumonia
1%
Cardiac failure chronic
1%
Ischaemic cardiomyopathy
1%
Ventricular tachycardia
1%
Incarcerated inguinal hernia
1%
Oesophageal spasm
1%
Hypersensitivity
1%
Diabetic ketoacidosis
1%
Hyperglycaemia
1%
Invasive ductal breast carcinoma
1%
Cervical radiculopathy
1%
Renal failure acute
1%
Hypotension
1%
Vascular compression
1%
Mitral valve incompetence
1%
Abdominal pain upper
1%
Lung neoplasm malignant
1%
Aortic aneurysm
1%
Appendicitis
1%
Infective exacerbation of chronic obstructive airways disease
1%
Angina pectoris
1%
Oedema peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Q2W
Alirocumab 75 mg Q2W/Up 150 mg Q2W
Alirocumab 300 mg Q4W/Up 150 mg Q2W

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Statin Naive - ARM 3Experimental Treatment1 Intervention
Patients on no pre-existing statin regimen will be randomized to Atorvastatin 10 mg or Atorvastatin 80 mg for ~2 weeks before their CEA
Group II: Less Than Maximal Dose - ARM 2Experimental Treatment2 Interventions
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.
Group III: Observational - Maximal Dose - ARM 1Active Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Statin
2011
Completed Phase 4
~110100
Atorvastatin
FDA approved

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,448 Previous Clinical Trials
2,531,459 Total Patients Enrolled
38 Trials studying Stroke
23,079 Patients Enrolled for Stroke
Edward S Connolly, MD, FACSPrincipal InvestigatorColumbia University Medical Center/New York Presbyterian
Eric Heyer, MD, Ph.D.Study DirectorColumbia University
~4 spots leftby Sep 2025
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