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Posted on 2 February 2021 | Posted in Evolocumab
Trial Effect of Evolocumab in Patients With Critical Limb Ischemia (Evol-CLI) Identifier: NCT04369664

Aim To investigate the effect of evolocumab in patients with CLI on maximally tolerated lipid lowering therapy with a statin for one year after an index CLI event, requiring revascularization
Study design Double-blinded, prospective, randomized, pilot study

Patients will be randomly allocated to evolocumab 420 mg monthly or placebo for 12 months

Patients 32 patients (between 40 and 85) with 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 a 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.

Primary outcome Change in low-density lipoprotein cholesterol (LDL-C) from baseline to 3 months
Key results Ongoing
Author conclusion  

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