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Effect of Evolocumab in Functional Status and LDL Oxidation of Patients With Peripheral Arterial Disease (Evol-PAD Trial)
Phase 4
Waitlist Available
Led By Leonardo Clavijo, MD, PhD
Research Sponsored by Leonardo Clavijo
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 six months
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will show if adding a PCSK-9 inhibitor to statin therapy can improve quality of life for patients with peripheral arterial disease by reducing pain, improving walking ability, and increasing blood flow to the extremities.
Eligible Conditions
- Peripheral Artery Disease
- Peripheral Arterial Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evolocumab effect in pain free walking time (PFWT) in patients with PAD
Secondary study objectives
Evolocumab effect in maximal walking time (MWT) in patients with PAD
Other study objectives
Evolocumab effect in brachial endothelial function by changes in Flow Mediated Dilation (FMD).
Evolocumab effect in lower extremity arterial perfusion in ankle-brachial indices (ABI).
Evolocumab effect in lower extremity arterial perfusion in transcutaneous oxygen changes.
+4 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
43 Patients with lower extremities Peripheral Arterial Disease on maximum statin therapy will receive in addition a monthly dose of evolocumab 420 mg via subcutaneous injections for 6 months.
Group II: Control ArmPlacebo Group1 Intervention
43 Patients with lower extremities Peripheral Arterial Disease on maximum statin therapy will receive in addition a monthly dose of placebo via subcutaneous injections for 6 months.
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Who is running the clinical trial?
Leonardo ClavijoLead Sponsor
2 Previous Clinical Trials
132 Total Patients Enrolled
AmgenIndustry Sponsor
1,466 Previous Clinical Trials
1,401,410 Total Patients Enrolled
Leonardo Clavijo, MD, PhD2.73 ReviewsPrincipal Investigator - University of Southern California
University of Southern California
4 Previous Clinical Trials
285 Total Patients Enrolled
2Patient Review
At first, I was content with the care I was receiving from Dr. Clavijo. My chest pain symptoms, however, persisted. The doctor then became very dismissive, attributing my symptoms to anxiety. Despite telling me that women's heart symptoms frequently present differently than men's, no diagnostics were done other than those routinely performed on male patients. When I saw him for a follow up visit due to my symptoms becoming more frequent and a little more severe, he brushed them off as anxiety and told me to address the real issue by seeing a psychiatrist, psychologist, and taking meds. He was very dismissive and gave the impression