Acute Coronary Syndrome
Conditions
Keywords
Half dose, Newer oral P2Y12 receptor inhibitors, Acute coronary syndrome
Brief summary
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).
Detailed description
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.
Interventions
Clopidogrel 600 mg as loading dose followed by 75 mg/day as maintenance dose.
DRUGPrasugrel 5 mg
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.
DRUGTicagrelor 45 mg
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.
Sponsors
Dong-A University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Open-labeled
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients present with acute coronary syndrome undergoing primary PCI. * Patients receive DAPT (conventional dose of P2Y12 inhibitors+aspirin) at least 1 month. * Patients provide written informed consent prior to enrollment.
Exclusion criteria
* Low body weight (\<60kg). * History of transient ischemic attack or stroke. * History of upper gastrointestinal bleeding in recent 6 months. * Renal dysfunction defined as serum creatinine \> 2.5 mg/dl * Severe hepatic dysfunction defined as serum transaminase \> 3 times normal limit * On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban). * Bleeding tendency. * Thrombocytopenia defined by platelet \< 100,000/ml. * Anemia defined by hemoglobin \< 10 g/dl. * Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin. * Known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (SSS) or high degree AV block without pacemaker protection). * Contraindication for study drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimal platelet reactivity (OPR) rate | At post-PCI 3 months. | OPR, indicate 85 to 208 for P2Y12 reaction units (PRU) or 16% to 50% for vasodilator-stimulated phosphoprotein (VASP)-platelet reactivity index (PRI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac and cerebrovascular events (MACCE) | Post-PCI 6 months. | MACCE: composite of cardiac death, non-fatal myocardial infarction, repeat revascularization and stroke |
| Bleeding events | Post-PCI 6 months. | BARC: Bleeding Academic Research Consortium (BARC ≥2). |
| Drug side effects | Post-PCI 6 months. | Dyspnea or ventricular pauses ≥3 sec |
Countries
South Korea
Outcome results
None listed