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TCD-10023PK Trial

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20 patients, single arm, pharmocokinetics. Published.

Objectives

  • Assess the pharmacokinetics of sirolimus after Ultimaster implantation 
  • Evaluate the systemic concentration and potential toxicity of sirolimus
  • Assess endothelial function
  • Investigate the safety and tolerability profile of Ultimaster, along with therapeutic outcomes

Stojkovic S et al. Fundam Clin Pharmacol 2014;29:95–105.


Study design

TCD_1.png

PK, pharmacokinetics.
Stojkovic S et al. Fundam Clin Pharmacol 2014;29:95–105; Data on file at Terumo Europe


Other findings

  • 6 months: 
    • Endothelial function well preserved
    • In-stent late loss: 0.10±0.28 mm
  • Up to 12 months:
    • No signs of sirolimus toxicity or other safety concerns

Stojkovic S et al. Fundam Clin Pharmacol 2014;29:95–105.