Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR)

Dong-A University

Status and phase: Completed; Phase 3

Conditions: Acute Coronary Syndrome

Treatments: Drug: Clopidogrel 75 mg; Drug: Ticagrelor 45 mg; Drug: Prasugrel 5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02944123

HOPE-TAILOR

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 3 patient groups

Clopidogrel 75 mg

Other group

Description:

Clopidogrel 600 mg as loading dose and followed by 75 mg/day as maintenance dose.

Treatment:

Drug: Clopidogrel 75 mg

Prasugrel 5 mg

Experimental group

Description:

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.

Treatment:

Drug: Prasugrel 5 mg

Ticagrelor 45 mg

Experimental group

Description:

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.

Treatment:

Drug: Ticagrelor 45 mg