ComparisoN of ticAgrelor vs. Clopidogrel in endoTHeliAl Function of COPD patieNts
Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
Summary
This is an investigator-initiated, prospective, single-centre, randomised, phase II,
open-label study, testing the superiority of ticagrelor, as compared to clopidogrel, in
modulating on-P2Y12 treatment platelet reactivity, endothelial dysfunction and inflammation
in chronic obstructive pulmonary disease (COPD) patients receiving scheduled percutaneous
coronary intervention (PCI) for stable coronary artery disease. Subjects that meet the
inclusion criteria and have provided informed consent will be randomly assigned in a 1:1
fashion to one of the two dual antiplatelet therapy (DAPT) regimen: aspirin + clopidogrel
(standard of care) vs. aspirin + ticagrelor (experimental arm).
DAPT with aspirin and clopidogrel for at least 6 months (preferably 12 months) is the current
gold-standard for patients receiving PCI and drug eluting stent implantation for SCAD. No
data supports a different strategy and/or approach in COPD patients undergoing PCI.
Ticagrelor, a new P2Y12 inhibitor, showed a significantly higher platelet inhibition as
compared to clopidogrel. Recently, ticagrelor administration has been associated with a
positive effect on endothelial function and a modulation of proinflammatory signalling. These
actions are mediated by a significant influence of adenosine uptake. Higher platelet
reactivity, chronic inflammatory response, heightened endothelial dysfunction characterized
COPD patients with concomitant coronary artery disease (CAD). The investigators speculated
that COPD patients undergoing PCI for stable CAD (SCAD) had a risk profile similar to that of
acute coronary syndromes (ACS) patients. Accordingly, COPD patients undergoing PCI for SCAD
may obtain a stronger benefit by ticagrelor as compared to clopidogrel. The aim of this study
is to evaluate whether ticagrelor, is superior to clopidogrel, in reducing endothelial
dysfunction , platelet reactivity (PR) and inflammation profile of patients with stable CAD
and COPD. Ticagrelor will be administered according PLATO trial and international guidelines
(180 mg as loading dose, 90 mg x 2 daily as maintenance dose). As suggested by international
guidelines, the control group will be patients with current gold standard treatment for SCAD
treated with PCI (aspirin + clopidogrel 75 mg daily). The evaluation of endothelial
dysfunction, PR and inflammation profile will be repeated after 30 days and will be compared
to baseline values.