Optimal Dosage of Ticagrelor in Korean Patients With AMI

NCT ID: NCT05210595

Last Updated: 2022-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Acute Myocardial Infarction Ticagrelor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Clopidogrel 75 mg/day as maintenance dose

Group Type EXPERIMENTAL

Clopidogrel 75 mg

Intervention Type DRUG

75 mg/day as maintenance dose.

Treatment group 1

De-escalation strategy dose receive ticagrelor 60 mg twice daily

Group Type EXPERIMENTAL

Ticagrelor 60mg

Intervention Type DRUG

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.

Treatment group 2

De-escalation strategy dose receive ticagrelor 45 mg twice daily

Group Type EXPERIMENTAL

Ticagrelor 45 mg

Intervention Type DRUG

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 .

Interventions

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Clopidogrel 75 mg

75 mg/day as maintenance dose.

Intervention Type 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.

Intervention Type 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 .

Intervention Type DRUG

Other Intervention Names

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Plavix 75 mg Brilinta 60 mg Brilinta 45 mg

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A University

OTHER

Sponsor Role lead

Responsible Party

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Moo Hyun Kim

Professor, Dept. of Cardiology Dong-A University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Moo Hyun Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Dong-A University Hospital

Locations

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DongA University Hospital

Busan, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Moo Hyun Kim, MD

Role: CONTACT

+82-51-240-2976

Facility Contacts

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Moo Hyun Kim, M.D.

Role: primary

+82-51-240-2976

Other Identifiers

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HOPE-TAILOR 2

Identifier Type: -

Identifier Source: org_study_id

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