NCT04306471 - Effect of Evolocumab in Patients With Critical Limb Ischemia (Evol-CLI) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 24, 2020

Primary Completion Date

February 4, 2021

Study Completion Date

February 4, 2022

Conditions

Critical Limb Ischemia

Interventions

DRUG

Evolocumab 140mg/mL Injector 1milliliter (mL) Pen x 3 for a monthly dose of 420 mg for 12 months.

The study subjects randomized to the treatment study arm will receive monthly subcutaneous injections of evolocumab 420 mg in the abdomen, thigh or upper arm. The study drug (evolocumab) prefilled injector pens are to be provided by Amgen.

OTHER

Placebo 1 milliliter (mL) Injector Pen x 3 monthly for 12 months

The study subjects randomized to the control study arm will receive monthly subcutaneous injections of placebo 1 mL x 3 in the abdomen, thigh or upper arm. The study placebo prefilled injector pens are to be provided by Amgen.

Trial Locations (1)

90033

RECRUITING

University of Southern California, Los Angeles