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PCSK9 Inhibitor

Alirocumab for Peripheral Arterial Disease

Phase 4
Waitlist Available
Led By Christopher M Kramer, MD
Research Sponsored by University of Virginia
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

Study Summary

This trial will test whether or not Alirocumab, a drug that effectively lowers LDL cholesterol, can also regress atherosclerotic plaque in the superficial femoral artery (SFA).

Eligible Conditions
  • Peripheral Arterial Disease

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
Change in superficial femoral plaque volume (summed from both legs)
Secondary outcome measures
Change in 6-minute walk test
Body Weight Changes
Change in calf muscle perfusion in the most symptomatic leg
+4 more

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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AlirocumabExperimental Treatment1 Intervention
Alirocumab 150mg SQ every 2 weeks
Group II: PlaceboPlacebo Group1 Intervention
Matched placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alirocumab
2012
Completed Phase 3
~23510

Find a Location

Who is running the clinical trial?

Northwestern UniversityOTHER
1,586 Previous Clinical Trials
917,211 Total Patients Enrolled
24 Trials studying Peripheral Arterial Disease
4,382 Patients Enrolled for Peripheral Arterial Disease
University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,245,033 Total Patients Enrolled
8 Trials studying Peripheral Arterial Disease
470 Patients Enrolled for Peripheral Arterial Disease
Christopher M Kramer, MDPrincipal InvestigatorUniversity of Virginia Health System
2 Previous Clinical Trials
2,766 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
16 Patients Enrolled for Peripheral Arterial Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Alirocumab been granted final authorization from the FDA?

"Due to its status as an approved Phase 4 medication, the safety of Alirocumab is rated a 3 on our team's scale."

Answered by AI

What therapeutic benefits can patients experience when taking Alirocumab?

"Generally, alirocumab is administered to treat myocardial infarction. However, it also can be used in tandem with dietary and lifestyle changes as a treatment for hypercholesterolemia and unstable angina pectoris."

Answered by AI

Who is eligible to participate in this clinical experiment?

"To gain entry into this clinical trial, potential participants must have peripheral arterial disease and be between the ages of 35 and 85. Approximately 40 candidates are being accepted for participation."

Answered by AI

How many people are being enrolled in this medical experiment?

"This investigation is no longer recruiting individuals. First posted on July 17th 2017 and last revised on May 16th 2022, the trial has concluded its recruitment process. If you are searching for other trials, 217 studies related to peripheral arterial disease are actively enrolling patients while 10 clinical investigations concerning Alirocumab are accepting participants at this time."

Answered by AI

Have there been any other exploratory studies involving the drug Alirocumab?

"In 2017, Alirocumab was tested for the first time at Northwestern University. 109 studies have been conducted since then, and currently 10 are ongoing in Charlottesville, Virginia."

Answered by AI

Does this research include participants under the age of forty-five?

"This study is open to individuals aged 35 or older, but younger than 85."

Answered by AI

Are any additional participants being sought for this research endeavor?

"This specific clinical trial is presently not enrolling patients. It was first posted on July 17th, 2017 and last edited on May 16th, 2022. For those with an interest in similar studies, there are 217 active trials for peripheral arterial disease participants and 10 recruiting for Alirocumab therapy currently available."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease
Christopher Kramer 2017. "A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02959047.
~5 spots leftby Apr 2025
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