Antiplatelet Effects of Evolocumab in Patients With Peripheral Arterial Disease

Part of paid clinical trials in Falls Church, Virginia.

Sponsor
Inova Health Care Services
Study ID
NCT03247972
Status
Terminated

Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    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.

Study Details

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

Key Dates

Start date
Aug 11, 2017
Status verified
Jun 2023
Primary completion
Sep 1, 2019
Completion
Oct 1, 2019

Study Design

Enrollment
30 participants (actual)

Arms

  • Arm: Patients with peripheral artery disease receiving evolocumab + high dose statins
    Adult patients with a history of Peripheral Artery Disease (PAD) defined as one or more of the following: * Documented history of PAD * Previous limb or foot amputation for arterial vascular disease (i.e., excludes trauma), * Carotid artery disease (defined as \>50% stenosis or prior revascularization )

Primary Outcome Measure

Difference Between ADP-induced % Maximum Platelet Aggregation Between V2 (After 8 Weeks of HD Statin Therapy) and V5 (8 Weeks of Continued HD Statin Therapy + Evolocumab) [ Time Frame: Change from week 8 (V2) to week 16 (V5) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Inova Fairfax HospitalFalls ChurchVirginia22042-

Find similar trials in Falls Church, VA

By research site
Inova Fairfax Hospital· Falls Church, VA

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