The primary outcome of the PRINCE trial was the proportion of patients with high platelet reactivity at 90 days. High platelet reactivity was defined as a P2Y12 reaction unit of more than 208 measured using the VerifyNow P2Y12 assay. Prespecified secondary outcomes included high platelet reactivity at 90 days (seven days either way) in patients carrying genetic variants that would affect clopidogrel metabolism; any stroke (ischaemic or haemorrhagic); and composite clinical vascular events (ischaemic/haemorrhagic stroke, transient ischaemic attack, myocardial infarction, or vascular death) at 90 days (seven days either way), six months, and one year. Each reported composite clinical vascular event and safety outcome was independently adjudicated by two members (KD and Jimei Li) of the clinical event adjudication committee, who were blinded to the treatment group assignments. All discrepancies were reviewed by all five members of the committee and resolved by consensus.
The primary safety outcome was major bleeding, which was defined as that in the PLATO study classification of haemorrhagic events: fatal or life threatening bleed, major bleed, and other (supplementary appendix, PLATO bleeding classification). Secondary safety outcomes included the incidence of intracranial bleeding; dyspnoea events; and mortality at 90 days (seven days either way), six months, and one year.
The primary safety outcome was major bleeding, which was defined as that in the PLATO study classification of haemorrhagic events: fatal or life threatening bleed, major bleed, and other (supplementary appendix, PLATO bleeding classification). Secondary safety outcomes included the incidence of intracranial bleeding; dyspnoea events; and mortality at 90 days (seven days either way), six months, and one year.
