Recruiting

Evolocumab

Sponsor:

Leonardo Clavijo

Code:

NCT04306081

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Evolocumab 140 mg/mL Subcutaneous Injection 1 milliliter (mL) pre-filled injector Pen x 3 for a monthly dose of 420 mg for 6 months.

Placebo 1milliliter (mL) Subcutaneous Injection pre-filled injector Pen x 3 monthly for 6 months.

Study Details

Brief summary:

Peripheral arterial disease (PAD) is a manifestation of systemic atherosclerotic cardiovascular disease (ASCVD) and is associated with increase cardiovascular risk. PAD impairs quality of life due to symptoms of claudication, pain at rest or risk of limb loss.

All major societies recognize the importance of LDL reduction in patients with PAD.

Statin therapy improves cardiovascular end-points in patients with PAD and have been shown to improve symptoms of lower extremity intermittent claudication (pain free walking time), 6-minute walking time, ankle-brachial index (ABI), and endothelial function, while decreasing markers of atherosclerosis.

This study aims to demonstrate that in patients with PAD on stable maximal tolerated lipid lowering regimen with a statin, further reduction of LDL with the pro protein converts subtilisin/kexin type 9 (PCSK-9) inhibitor Evolocumab, improves functional status (pain free walking time in particular, but also maximal walking time), lower extremity arterial perfusion and endothelial function (brachial endothelial reactivity).

Conditions

Peripheral Arterial Disease

Study ID

NCT04306081

Start date

Dec 14, 2017

Status verified date

Mar, 2020

Completion date

Mar 30, 2021

Anticipated

Primary completion date

Dec 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Signed informed consent.
  • Age ≥40 to ≤85 years of age at the time of consent.
  • Diagnosis of ASCVD with peripheral arterial disease, Rutherford class I-VI at the time of diagnosis, confirmed by ABI≤0.9 at rest or ABI≤0.8 after exercise, angiography, duplex ultrasound or history of lower extremity surgical or endovascular revascularization.
  • At least 1 months from last intervention, including surgery or endovascular procedures.
  • Stable on maximal tolerated doses of a lipid-lowering regimen for at least 4 weeks.
  • Most recent fasting LDL-C ≥55 mg/dL or non-HDL-C ≥80 mg/dL.

Exclusion Criteria:

  • Subjects with active, non-healed wounds.
  • Subjects with anticipated need of cardiac or surgical revascularization procedures.
  • Subjects with chronic inflammatory conditions or requiring chronic systemic corticosteroids.
  • New York Heart Association (NYHA) class III or IV heart failure, or known left ventricular ejection fraction <30%.
  • Uncontrolled arrhythmia.
  • Uncontrolled hypertension with systolic BP>180 mmHg or diastolic >100 mmHg.
  • Untreated thyroid disease.
  • Severe chronic renal disease with estimated glomerular filtration rate (eGFR) <20 mL/min.
  • Liver disease with aspartame aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times the upper limit of normal.
  • Status post-organ transplant.
  • Pregnant and breastfeeding women
  • Fertile age female not on appropriate birth control.
  • Clinically significant disease that, in the opinion of the Principal Investigator, is likely to require surgery or immunotherapy that may interfere with the completion of the study.
  • Active cancer or life expectancy of less than two years.
  • Chronic anticoagulation or hypercoagulability disorder.
  • Atrial fibrillation with a CHADS-VASc Score ≥2 or any clinical condition which, in the opinion of the Principal Investigator increases the risk of cerebrovascular events.

Study Design

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

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.

placebo comparator: Control Arm

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.

Interventions

Evolocumab 140 mg/mL Subcutaneous Injection 1 milliliter (mL) pre-filled injector Pen x 3 for a monthly dose of 420 mg for 6 months.

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 provided by Amgen

Placebo 1milliliter (mL) Subcutaneous Injection pre-filled injector Pen x 3 monthly for 6 months.

The study subjects randomized to the treatment study arm will receive monthly subcutaneous injections of Placebo in the abdomen, thigh or upper arm. The Placebo prefilled injector pens are provided by Amgen

Primary outcome measure

  • Evolocumab effect in pain free walking time (PFWT) in patients with PAD [ Time Frame: six months ]

Central Contacts and Locations

Central contacts

Jorge Caro, MPH

323-382-7646Jorge.Caro@med.usc.edu

Melissa Ramos, RN

323-442-7983Melissa.Ramos@med.usc.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Jorge Caro, MPH

323-382-7646Jorge.Caro@med.usc.edu

Melissa Ramos, RN

323-442-7983Melissa.Ramos@med.usc.edu

More Information

Sponsor

Leonardo Clavijo

Last update posted

Mar 12, 2020

Last verified

Mar, 2020

Keywords

  • PAD
  • Hyperlipidemia
  • Claudication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Leonardo Clavijo on 2020-03-12.