Optimal Dosage of Ticagrelor in Korean Patients With AMI

Sponsor

Dong-A University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05210595

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction Ticagrelor	Drug: Clopidogrel 75 mg Drug: Ticagrelor 60mg Drug: Ticagrelor 45 mg	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control group Clopidogrel 75 mg/day as maintenance dose	Drug: Clopidogrel 75 mg 75 mg/day as maintenance dose. Other Names: Plavix 75 mg
Experimental: Treatment group 1 De-escalation strategy dose receive ticagrelor 60 mg twice daily	Drug: Ticagrelor 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. Other Names: Brilinta 60 mg
Experimental: Treatment group 2 De-escalation strategy dose receive ticagrelor 45 mg twice daily	Drug: Ticagrelor 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 . Other Names: Brilinta 45 mg

Arm

Intervention/Treatment

Experimental: Control group

Clopidogrel 75 mg/day as maintenance dose

Drug: Clopidogrel 75 mg

75 mg/day as maintenance dose.

Other Names:

Plavix 75 mg

Experimental: Treatment group 1

De-escalation strategy dose receive ticagrelor 60 mg twice daily

Drug: Ticagrelor 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.

Other Names:

Brilinta 60 mg

Experimental: Treatment group 2

De-escalation strategy dose receive ticagrelor 45 mg twice daily

Drug: Ticagrelor 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 .

Other Names:

Brilinta 45 mg

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.