NCT03247972

Antiplatelet Effects of Evolocumab in Patients With Peripheral Arterial Disease

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This investigation will be conducted in subjects \>18 years of age with PAD. Platelet activation and aggregation, and biomarkers associated with platelet activation, oxidative stress, and inflammation will be assessed prior to initiation of study-HD statin therapy (baseline), after 8 weeks of high-dose statins and 24 hours and 8 weeks after high dose statin + evolocumab therapy

Detailed description

Monoclonal antibodies against PCSK9 are innovative agents that provide very potent LDL reduction when administered on top of statins. PCSK9 antibodies prevent LDL receptor degradation and enhance circulatory LDL cholesterol clearance. High LDL is a major risk factor for PAD and therefore lipid-lowering therapy constitutes another important therapeutic intervention for patients with PAD. Evolocumab is a common PCSK-9 inhibitor that has been shown to reduce plasma LDL. In this study sixty subjects will be treated with high dose statins for 8 weeks followed by 8 weeks of high dose statin + evolocumab (420mg/4 wk) therapy to determine the effect of Repatha on markers of cholesterol, thrombosis, and inflammation.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	Evolocumab	Sixty subjects will be treated with high dose statins for 8 weeks followed by 8 weeks of high dose statin + evolocumab (420mg/4 wk) therapy.

Timeline

• Start date: 2017-08-11
• Primary completion: 2019-09-01
• Completion: 2019-10-01
• First posted: 2017-08-14
• Last updated: 2024-02-16
• Results posted: 2024-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study