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

First listed
Aug 14, 2017
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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