A Study of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArt… (NCT04539223) | Clinical Trial Compass
UnknownPhase 4
A Study of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArterectomy
Canada60 participantsStarted 2020-08-28
Plain-language summary
This is a multicenter, randomized, open label study with blinded outcome assessment to evaluate the impact of additional/intensive LDL-cholesterol reduction with evolocumab on carotid artery atherosclerotic plaques in higher risk subjects with severe asymptomatic but vulnerable plaques.
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. Age ≥ 40 years old
✓. Significant (70-99%) carotid artery stenosis on one side, as measured by duplex ultrasound or angiogram
✓. Asymptomatic carotid stenosis (no history of ipsilateral stroke or TIA within 180 days)
✓. Deemed to be fit for carotid endarterectomy
✓. At least one of the following high-risk features: (a) prior stroke \>6months prior to randomization; (b) peripheral artery disease; (c) current smoker; (d) type 2 diabetes; (e) eGFR ≥ 30 mL/min/1.73m2 and \<60 ml/min/1.73m2; (f) hsCRP \> 2mg/L in the absence of alternative known causes of hsCRP elevations including autoimmune diseases or active infections.
✓. On a moderate to high intensity statin therapy (defined as atorvastatin 40-80mg daily, rosuvastatin 20-40mg or simvastatin 40mg daily) unless a lower dose, or another statin or non-statin therapy is clinically justified
Exclusion criteria
✕. Contraindications for MRI (pacemaker; neurostimulator; non-removable metal fragments in the eye; etc.)
✕. Patients in whom additional lowering of LDL-C with evolocumab is deemed to be clinically inappropriate
✕. Currently taking simvastatin \>40mg/day
✕. High risk comorbidities such as severe heart failure, severe COPD, severe renal disease, known severe hepatic impairment, unstable coronary syndrome, and/or advanced dementia
✕
What they're measuring
1
Change in lipid rich necrotic core (LRNC) volume
Timeframe: Baseline to end of treatment (average of 6 months)
Trial details
NCT IDNCT04539223
SponsorCanadian Medical and Surgical Knowledge Translation Research Group