| 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 |
| Key results | Ongoing |
| Safety | |
| Author conclusion | |
| Publication | |
| Link | https://clinicaltrials.gov/ct2/show/NCT04306471 |
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