|Trial||Effect of Evolocumab in Patients With Critical Limb Ischemia (Evol-CLI)
ClinicalTrials.gov 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|