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Monoclonal Antibodies

Open Label for Atherosclerosis

Phase 4
Waitlist Available
Led By Norman Lepor, MD
Research Sponsored by Westside Medical Associates of Los Angeles
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 52 weeks
Awards & highlights

Study Summary

Aim 1: To determine whether therapy with Alirocumab, compared to pre-treatment, will effectively improve carotid atherosclerotic plaque characteristics by reducing Ktrans and LRNC size. To achieve this goal, we will (a) enroll 30 subjects who are intolerant to high intensity statin therapy and only able to tolerate low potency statin or low weekly dose of high potency statin and have LDL-C ≥70 mg/dl; (b) initiate alirocumab at 150mg subcutaneously injection every 2 weeks; (c) perform carotid DCE-MRI scans at baseline, 3, 6 and 12 months; (d) perform quantitative analysis for vascular inflammation and plaque LRNC volume and other plaque characteristics; (e) compare vascular inflammation and LRNC volume between pre- and post-alirocumab at 3, 6 and 12 months. Aim 2: To examine associations between reductions in atherogenic lipids (LDL-C, Lp(a), non-HDL-C) and changes in atherosclerotic plaque characteristics. To achieve this goal, we will (a) perform laboratory assessments of lipids, lipoproteins and apo-lipoproteins at baseline and during the study; (b) compare lipids, lipoproteins and apo-lipoproteins levels between pre- and post-alirocumab; (c) correlate reductions in atherogenic lipids with changes atherosclerotic plaque characteristics.

Eligible Conditions
  • Atherosclerosis
  • High Cholesterol

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in carotid atherosclerotic plaque characteristics as evidenced by effect on the volume transfer constant( Ktrans) and lipid-rich necrotic core (LRNC) size.
Secondary outcome measures
Atherosclerosis

Side effects data

From 2017 Phase 3 trial • 233 Patients • NCT02023879
15%
Viral upper respiratory tract infection
13%
Fall
10%
Diarrhoea
9%
Back pain
8%
Upper respiratory tract infection
8%
Hypertension
8%
Influenza
8%
Cough
7%
Urinary tract infection
7%
Fatigue
7%
Osteoarthritis
7%
Arthralgia
7%
Injection site reaction
7%
Depression
6%
Musculoskeletal pain
6%
Myalgia
6%
Headache
5%
Oedema peripheral
5%
Non-cardiac chest pain
5%
Dizziness
5%
Gout
4%
Muscle spasms
4%
Bronchitis
3%
Nausea
3%
Rash
3%
Laceration
3%
Acute myocardial infarction
3%
Syncope
3%
Pain in extremity
3%
Sinusitis
2%
Cardiac failure congestive
2%
Basal cell carcinoma
2%
Presyncope
2%
Hypotension
2%
Coronary artery disease
2%
Prostate cancer
1%
Femur fracture
1%
Retinal detachment
1%
Hypovolaemic shock
1%
Small intestinal obstruction
1%
Pharyngitis
1%
Arachnoiditis
1%
Device related infection
1%
Myocardial infarction
1%
Retroperitoneal haematoma
1%
Gastrointestinal haemorrhage
1%
Basedow's disease
1%
Vertigo
1%
Intentional overdose
1%
Bladder transitional cell carcinoma
1%
Post procedural haematoma
1%
Suicide attempt
1%
Haemorrhagic anaemia
1%
Abdominal pain
1%
Cerebrovascular accident
1%
Hyperkalaemia
1%
Aortic valve stenosis
1%
Abdominal wall haematoma
1%
Chest pain
1%
Cholelithiasis
1%
Pneumonia
1%
Subdural haematoma
1%
Vascular pseudoaneurysm
1%
Spinal osteoarthritis
1%
Skin cancer
1%
Multiple sclerosis relapse
1%
Transient ischaemic attack
1%
Haematoma
1%
Peripheral ischaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alirocumab 150 mg Q4W (After Alirocumab 75 Q2W/Up150 Q2W)
Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W)
Alirocumab 150 mg Q4W/Up150 mg Q2W
Alirocumab 75 mg Q2W/Up150 mg Q2W
Placebo Q2W
Alirocumab 150 mg Q4W (After Placebo Q2W)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
All enrolled patients will receive open label Praluent (Alirocumab).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alirocumab
FDA approved

Find a Location

Who is running the clinical trial?

Westside Medical Associates of Los AngelesLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
University of WashingtonOTHER
1,741 Previous Clinical Trials
1,847,731 Total Patients Enrolled
11 Trials studying Atherosclerosis
5,371 Patients Enrolled for Atherosclerosis
Regeneron PharmaceuticalsIndustry Sponsor
621 Previous Clinical Trials
380,570 Total Patients Enrolled
4 Trials studying Atherosclerosis
26,648 Patients Enrolled for Atherosclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Apr 2025