East Asian patients will be required optimal dose of newer P2Y12 inhibitors (prasugrel or ticagrelor) to determine the safer treatment and better outcome. Whether lower dose of these regimens are more adequate for clinical practice in Korea is unclear. Therefore, the investigators aim to evaluate efficacy and safety of half dose of new oral P2Y12 inhibitors in Korean patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).
In recent years, newer oral P2Y12 receptor blockers (prasugrel or ticagrelor) have been strong recommendations for management of patients with ACS undergoing (PCI). These drugs provided more profound inhibitory effects than clopidogrel, which could lead to marked reduction in ischemic events, with relatively increase in bleeding complication, specific to low body weight, especially in women and East Asian patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Clopidogrel 600 mg as loading dose followed by 75 mg/day as maintenance dose.
Loading / maintenance dose: prasugrel 60 mg / 10 mg/day; After 1-month treatment of conventional dose, followed half dose of 5 mg/day for chronic treatment.
Loading / maintenance dose: ticagrelor 180 mg / 90 mg/bid; After 1-month treatment of conventional dose, followed half dose of 45 mg/bid for chronic treatment.
Dong-A University Hospital
Busan, South Korea
Optimal platelet reactivity (OPR) rate
OPR, indicate 85 to 208 for P2Y12 reaction units (PRU) or 16% to 50% for vasodilator-stimulated phosphoprotein (VASP)-platelet reactivity index (PRI)
Time frame: At post-PCI 3 months.
Major adverse cardiac and cerebrovascular events (MACCE)
MACCE: composite of cardiac death, non-fatal myocardial infarction, repeat revascularization and stroke
Time frame: Post-PCI 6 months.
Bleeding events
BARC: Bleeding Academic Research Consortium (BARC ≥2).
Time frame: Post-PCI 6 months.
Drug side effects
Dyspnea or ventricular pauses ≥3 sec
Time frame: Post-PCI 6 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.