Key result
HOPE-TAILOR trial evaluates half-dose prasugrel and ticagrelor versus clopidogrel in Korean ACS patients.
Why the study?
The optimal dosing of novel oral P2Y12 receptor inhibitors such as prasugrel or ticagrelor is unclear and challenging in East Asians with ACS.
RCT (n=100)
Open-label, blinded endpoint
randomly assigned
No
Half-dose de-escalation may not optimize platelet reactivity in Korean ACS patients; leaves open tailored dosing trials in East Asians.
BACKGROUND: The optimal dosing of novel oral P2Y12 receptor platelet inhibitors such as prasugrel or ticagrelor is unclear and especially challenging in East Asians. We hypothesize that half-dose prasugrel and ticagrelor may be sufficient for long-term maintenance management in Korean patients with the acute coronary syndrome (ACS) compared with conventional dosages. DESIGN: HOPE-TAILOR (Half Dose of Prasugrel and Ticagrelor in Platelet Response after Acute Coronary Syndromes) is a prospective, randomized, open-label, blinded, endpoint (PROBE) single-center, clinical trial. A total of 100 patients with ACS undergoing drug-eluting stent implantation will be randomly assigned to prasugrel, ticagrelor, or clopidogrel, and the patients in each treatment group will receive 1-month therapy with 100 mg q.d. aspirin plus prasugrel 10 mg q.d., ticagrelor 90 mg b.i.d., or clopidogrel 75 mg q.d., followed by half-dose prasugrel 5 mg q.d. or ticagrelor 45 mg b.i.d. for maintenance treatment but without clopidogrel dose reduction. The primary endpoint will be optimal platelet reactivity 3 months after coronary intervention, defined by VerifyNow Analyzer (PRU: 85-208) and vasodilator-stimulated phosphoprotein P2Y12 flow cytometry assay (platelet reactivity indices: 16-50%). Clinical outcomes will also be assessed, including major efficacy (composite of cardiac death, nonfatal myocardial infarction, repeat revascularization, or stroke) and safety (bleeding ≥2 according to the Bleeding Academic Research Consortium). CONCLUSION: HOPE-TAILOR is a prospective, randomized, open-label, blinded, endpoint study to explore the efficacy and safety of novel P2Y12 receptor inhibitors administered orally at half the dose in Korean patients with ACS. The results will be available late in 2017.
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Jin et al. (2017) conducted an RCT in Acute coronary syndrome (n=100). Prasugrel or ticagrelor vs. Clopidogrel 75 mg q.d. was evaluated on Optimal platelet reactivity 3 months after coronary intervention, defined by VerifyNow Analyzer and vasodilator-stimulated phosphoprotein P2Y12 flow cytometry assay. The HOPE-TAILOR trial is an ongoing study designed to evaluate half-dose prasugrel and ticagrelor versus clopidogrel in 100 Korean patients with ACS, with results expected in late 2017.
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