Effect of Evolocumab in Patients With Critical Limb Ischemia (Evol-CLI)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Leonardo Clavijo
Study ID
NCT04306471
Phase
PHASE4
Status
Unknown

Conditions

  • Critical Limb Ischemia

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab 140mg/mL Injector 1milliliter (mL) Pen x 3 for a monthly dose of 420 mg for 12 months. — DRUG
    The study subjects randomized to the treatment study arm will receive monthly subcutaneous injections of evolocumab 420 mg in the abdomen, thigh or upper arm. The study drug (evolocumab) prefilled injector pens are to be provided by Amgen.
  • Placebo 1 milliliter (mL) Injector Pen x 3 monthly for 12 months — OTHER
    The study subjects randomized to the control study arm will receive monthly subcutaneous injections of placebo 1 mL x 3 in the abdomen, thigh or upper arm. The study placebo prefilled injector pens are to be provided by Amgen.

Study Details

Critical limb ischemia (CLI), is the most severe form of peripheral arterial disease (PAD), and clinically is characterized by pain at rest or non-healing ulcers of the lower extremities. Also, is associated with increased risk of cardiovascular death, myocardial infarction (MI), stroke and amputation. Feringa et al. demonstrated in a study of 1,374 patients with PAD that all cause and cardiac related mortality rates were lower in patients at higher statin dose and lower levels of low-density lipoprotein cholesterol (LDL). Patients with CLI statin therapy and lower LDL levels improve amputation-free survival and patency after revascularization procedures. In the FOURIER trial, LDL cholesterol reduction with the PCSK9 inhibitor evolocumab in patients with symptomatic PAD with or without prior myocardial infarction or stroke was associated with improved major adverse cardiac events (MACE) and major adverse limb events (MALE) at 2-years. The effect of evolocumab in patients with CLI , after a recent arterial revascularization and active wounds is not known, also it is not known whether the cholesterol lowering effect of evolocumab in this group of patients is equivalent to that of non-CLI PAD patients and what the effect is on arterial perfusion, wound healing and other biological markers of vascular physiology. This study aims to investigate the effect of evolocumab in patients with CLI on maximally tolerated lipid lowering therapy with a statin for one year after an index CLI event, requiring revascularization.

Key Dates

Start date
Feb 24, 2020
Status verified
Mar 2020
Primary completion
Feb 4, 2021
Completion
Feb 4, 2022

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    16 Patients with Critical Limb Ischemia on maximum statin therapy will receive in addition the study intervention involving a monthly subcutaneous injection of evolocumab 420 mg for 12 months
  • Placebo Comparator: Control arm
    16 Patients with Critical Limb Ischemia on maximum statin therapy will receive in addition a Placebo subcutaneous injection for 12 months.

Primary Outcome Measure

Evolocumab effect on LDL cholesterol changes in patients with Critical Limb Ischemia [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033
Jorge Caro, MPH
[email protected]
323-382-7646
Melissa Ramos, RN
[email protected]
323-442-7983

Find similar trials in Los Angeles, CA

By research site
University of Southern California· Los Angeles, CA

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