Optimal Dosage of Ticagrelor in Korean Patients With AMI

Phase 4

• Conditions: Acute Myocardial Infarction; Ticagrelor
• Interventions: Drug: Clopidogrel 75 mg; Drug: Ticagrelor 60mg; Drug: Ticagrelor 45 mg

• Registration Number: NCT05210595
• Lead Sponsor: Dong-A University

Brief Summary

East Asian patients will be required optimal dose of newer P2Y12 inhibitor (ticagrelor) to determine the safer treatment and better outcome. Whether low dose of ticagrelorI is more adequate for clinical practice in Korea is unclear. Therefore, the investigators aim to evaluate efficacy and safety of low dose of ticagrelor in Acute Myocardial Infarction (AMI) undergoing percutaneous coronary intervention(PCI).

Detailed Description

In recent years, newer oral P2Y12 receptor blocker (ticagrelor) has been strong recommendations for management of patients with AMI undergoing (PCI). This drug 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 Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-01
• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Last Update Submitted: 2022-01-14
• Study First Posted: 2022-01-27
• Last Update Posted: 2022-01-27
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients present with acute myocardial infarction undergoing PCI.
• Patients receiving ticagrelor; Male or female gender; Age 20-75 years.
• Patients provide written informed consent prior to enrollment.

Exclusion Criteria

• Low body weight (<60kg).
• History of hemorrhagic stroke.
• History of upper gastrointestinal bleeding in recent 6 months.
• Bleeding tendency.
• Thrombocytopenia defined by platelet < 100,000/ml.
• Anemia defined by hemoglobin < 10 g/dl.
• Renal dysfunction defined as serum creatinine > 2.5 mg/dl.
• Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit.
• Known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (SSS) or high degree AV block without pacemaker protection).
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Clopidogrel 75 mg	Clopidogrel 75 mg/day as maintenance dose
Treatment group 1	Ticagrelor 60mg	De-escalation strategy dose receive ticagrelor 60 mg twice daily
Treatment group 2	Ticagrelor 45 mg	De-escalation strategy dose receive ticagrelor 45 mg twice daily

Primary Outcome Measures

Name	Time	Method
Optimal platelet reactivity (OPR) rate	At 1 month	OPR, indicate 85 to 208 for P2Y12 reaction units (PRU)

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebrovascular events (MACCE)	At 9 months	MACCE: composite of cardiac death, non-fatal myocardial infarction, target lesion / vessel revascularization and stroke
Bleeding events	At 9 months.	BARC: Bleeding Academic Research Consortium (BARC ≥2).

Trial Locations

Locations (1)

DongA University Hospital; 🇰🇷 Busan, Korea, Republic of