Antiplatelet Effects of Evolocumab in Patients With Peripheral Arterial Disease

Criteria: Inclusion Criteria:

Symptomatic PAD, as evidenced by either

- intermittent claudication with ABI <0.90, or

- peripheral arterial revascularization procedure, or

- amputation due to atherosclerotic disease.

- Subject may be of either sex and of any race, and must be >18 years of age.

- Subject agrees to not participate in any other investigational or invasive clinical
study for a period of 4 months during the study period

- Subject must be willing and able to give appropriate informed consent.

- The subject is able to read and has signed and dated the informed consent document
including authorization permitting release of personal health information approved by
the investigator's Institutional Review Board (IRB).

Exclusion Criteria:

- Prior use of any PCSK9 inhibition treatment Participation in any investigational study
within the last 60 days.

- Severe renal dysfunction, defined as an eGFR <20 mL/min/1.73 m2 at screening

- Active liver disease or hepatic dysfunction, defined as AST or ALT >3 x ULN as
determined by central laboratory analysis at screening

- Recipient of any major organ transplant (e.g., lung, liver, heart, bone marrow, renal)

- Known major active infection or major hematologic, renal, metabolic, gastrointestinal,
or endocrine dysfunction in the judgment of the investigator

- Malignancy (except non-melanoma skin cancers, cervical in situ carcinoma, breast
ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 10 years

- Subject has received drugs via a systemic route that have known major interactions
with background statin therapy within 1 month before randomization or is likely to
require such treatment during the study period (e.g. cyclosporine, clarithromycin, HIV
protease inhibitors, gemfibrozil)

- Female subject who is unwilling to use at least 2 effective birth control methods for
at least 1 month before screening and 15 weeks after the end of treatment with
investigational products, unless the subject is sterilized or postmenopausal.

- Subject is pregnant or breast feeding, or planning to become pregnant or to breastfeed
during receipt of investigational products and within 15 weeks after the end of study
treatment

- Known previous hypersensitivity reaction/s to the investigational products' active
components and excipients.

- Subjects treated with any antithrombotic agents except aspirin.

- Subject likely to not be available to complete all protocol-required study visits or
procedures, to the best of the subject's and investigator's knowledge

- History or evidence of any other clinically significant disorder, condition, or
disease other than those outlined above that, in the opinion of the investigator, may
compromise the ability of the subject to give written informed consent, would pose a
risk to subject safety or interfere with the study evaluation, procedures, or
completion.