Status:
UNKNOWN
Effect of Evolocumab in Patients With Critical Limb Ischemia (Evol-CLI)
Lead Sponsor:
Leonardo Clavijo
Collaborating Sponsors:
Amgen
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
40-85 years
Phase:
PHASE4
Brief Summary
Critical limb ischemia (CLI), is the most severe form of peripheral arterial disease (PAD), and clinically is characterized by pain at rest or non-healing ulcers of the lower extremities. Also, is ass...
Detailed Description
This is a double-blinded, prospective, randomized, pilot, study in thirty-two subjects with clinical CLI on background treatment with a statin. Subjects will be assessed based on their medical history...
Eligibility Criteria
Inclusion
- Signed informed consent.
- Age ≥40 to ≤85 years of age at the time of consent.
- Diagnosis CLI, Rutherford class IV to VI at the time of diagnosis, toe pressure ≤30 mmHg in non-diabetics or ≤40 mmHg in diabetics, angiography, duplex ultrasound or history of lower extremity surgical or endovascular revascularization for CLI.
- Stable on maximal tolerated dose of a statin, defined as the highest dose of statin (preferably atorvastatin or rosuvastatin) tolerated by the patient without side effects for at least one month.
Exclusion
- Less than 1 month from last revascularization procedure including surgery or endovascular procedures.
- Subjects with active infection.
- Diabetes therapy with canagliflozin
- Subjects who in the opinion of the Principal Investigator will likely require additional. amputation or revascularization procedures during the duration of the study.
- 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 aspartate 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 :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 4 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04306471
Start Date
February 24 2020
End Date
February 4 2022
Last Update
March 13 2020
Active Locations (1)
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1
University of Southern California
Los Angeles, California, United States, 90033