Optimal Dosage of Ticagrelor in Korean Patients With AMI

Acute Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05210595
• Other study ID #: HOPE-TAILOR 2
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2022
• Source: Dong-A University
• Contact: Moo Hyun Kim, MD
• Phone: +82-51-240-2976
• Email: kimmh[@]dau.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Ticagrelor

Intervention

Drug:
• Clopidogrel 75 mg
75 mg/day as maintenance dose.
• 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.
• 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 .

Locations

Country	Name	City	State
Korea, Republic of	DongA University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal platelet reactivity (OPR) rate	OPR, indicate 85 to 208 for P2Y12 reaction units (PRU)	At 1 month
Secondary	Major adverse cardiac and cerebrovascular events (MACCE)	MACCE: composite of cardiac death, non-fatal myocardial infarction, target lesion / vessel revascularization and stroke	At 9 months
Secondary	Bleeding events	BARC: Bleeding Academic Research Consortium (BARC =2).	At 9 months.