Status:
UNKNOWN
Effect of Evolocumab in Functional Status and LDL Oxidation of Patients With Peripheral Arterial Disease
Lead Sponsor:
Leonardo Clavijo
Collaborating Sponsors:
Amgen
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40-85 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
This is a double-blinded, prospective, randomized, study in eighty-six subjects with clinical ASCVD with PAD on background treatment with maximal tolerated dose of a statin. Subjects will be assessed ...
Eligibility Criteria
Inclusion
- Signed informed consent.
- Age ≥40 to ≤85 years of age at the time of consent.
- Diagnosis of ASCVD with peripheral arterial disease, Rutherford class I-VI at the time of diagnosis, confirmed by ABI≤0.9 at rest or ABI≤0.8 after exercise, angiography, duplex ultrasound or history of lower extremity surgical or endovascular revascularization.
- At least 1 months from last intervention, including surgery or endovascular procedures.
- Stable on maximal tolerated doses of a lipid-lowering regimen for at least 4 weeks.
- Most recent fasting LDL-C ≥55 mg/dL or non-HDL-C ≥80 mg/dL.
Exclusion
- Subjects with active, non-healed wounds.
- Subjects with anticipated need of cardiac or surgical revascularization procedures.
- Subjects with chronic inflammatory conditions or requiring chronic systemic corticosteroids.
- New York Heart Association (NYHA) class III or IV heart failure, or known left ventricular ejection fraction \<30%.
- Uncontrolled arrhythmia.
- Uncontrolled hypertension with systolic BP\>180 mmHg or diastolic \>100 mmHg.
- Untreated thyroid disease.
- Severe chronic renal disease with estimated glomerular filtration rate (eGFR) \<20 mL/min.
- Liver disease with aspartame aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times the upper limit of normal.
- Status post-organ transplant.
- Pregnant and breastfeeding women
- Fertile age female not on appropriate birth control.
- Clinically significant disease that, in the opinion of the Principal Investigator, is likely to require surgery or immunotherapy that may interfere with the completion of the study.
- Active cancer or life expectancy of less than two years.
- Chronic anticoagulation or hypercoagulability disorder.
- Atrial fibrillation with a CHADS-VASc Score ≥2 or any clinical condition which, in the opinion of the Principal Investigator increases the risk of cerebrovascular events.
Key Trial Info
Start Date :
December 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2021
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04306081
Start Date
December 14 2017
End Date
March 30 2021
Last Update
March 12 2020
Active Locations (1)
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1
University of Southern California
Los Angeles, California, United States, 90033