Optimal Dosage of Ticagrelor in Korean Patients With AMI

The Early De-escalation Strategy With Ticagrelor 60 mg or 45 mg on Platelet Reactivity and Clinical Outcomes in Korean Patients With Acute Myocardial Infarction

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05210595

Enrollment

120

Registered

2022-01-27

Start date

2022-01-01

Completion date

2023-12-31

Last updated

2022-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Ticagrelor

Keywords

Ticagrelor, De-escalation Strategy, Korean

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.

Interventions

DRUGClopidogrel 75 mg

75 mg/day as maintenance dose.

DRUGTicagrelor 60mg

In-hospital treatment with standard strategy ticagrelor 90mg twice daily, following de-escalation strategy ticagrelor 60 twice daily after discharge or post PCI 1 week.

DRUGTicagrelor 45 mg

In-hospital treatment with standard strategy ticagrelor 90mg twice daily, following de-escalation strategy ticagrelor 45 twice daily after discharge or post PCI 1 week .

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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).

Countries

South Korea

Contacts

Primary ContactMoo Hyun Kim, MD

kimmh@dau.ac.kr+82-51-240-2976

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026