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Caristo Chosen by Leading Pharma Company as Worldwide Imaging Core Lab to Measure Coronary Plaque and Inflammation

  • Caristo Diagnostics serves as the worldwide imaging core lab for NewAmsterdam Pharma's REMBRANDT clinical trial.
  • The trial utilizes Caristo's CaRi-Heart® and CaRi-Plaque™ technologies to measure & monitor coronary inflammation & plaque.
  • REMBRANDT is a placebo-controlled, double-blind, randomized trial assessing the efficacy of obicetrapib & ezetimibe fixed dose combination (FDC) on coronary plaque burden.
  • The study recruits patients from 50 sites across 7 countries: United States, Poland, United Kingdom, Czech Republic, Hungary, Italy, & Spain.
  • The primary efficacy outcome is the percent change in noncalcified coronary atherosclerotic plaque volume (NCPV) from baseline to 18 months via coronary computed tomographic angiography (CCTA).
  • Secondary endpoints include absolute NCPV changes, LDL-C changes, & the perivascular fat attenuation index (FAI-Score™), a proprietary biomarker for coronary inflammation.
  • Caristo's responsibilities include certifying & training clinical sites, conducting baseline & follow-up analyses at 6 & 18 months, & ensuring rigorous image quality control & data anonymization.
  • Obicetrapib is an investigational cholesteryl ester transfer protein (CETP) inhibitor that has demonstrated LDL-C lowering in three Phase 3 clinical trials.