drugset / Trial / NCT04306081

Effect of Evolocumab in Functional Status and LDL Oxidation of Patients With Peripheral Arterial Disease

NCT04306081

Phase 4 Unknown 86 enrolled Leonardo Clavijo Amgen · collab
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2017-12-14
Primary completion
2020-12-30
Completion
2021-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Evolocumab Monoclonal antibody 420 mg Subcutaneous