Optimal Dosage of Ticagrelor in Korean Patients With AMI
NCT ID: NCT05210595
Last Updated: 2022-01-27
Study Results
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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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2022-01-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
Clopidogrel 75 mg/day as maintenance dose
Clopidogrel 75 mg
75 mg/day as maintenance dose.
Treatment group 1
De-escalation strategy dose receive ticagrelor 60 mg twice daily
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.
Treatment group 2
De-escalation strategy dose receive ticagrelor 45 mg twice daily
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 .
Interventions
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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 .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients receiving ticagrelor; Male or female gender; Age 20-75 years.
* Patients provide written informed consent prior to enrollment.
Exclusion Criteria
* 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.
20 Years
75 Years
ALL
No
Sponsors
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Dong-A University
OTHER
Responsible Party
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Moo Hyun Kim
Professor, Dept. of Cardiology Dong-A University Hospital
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HOPE-TAILOR 2
Identifier Type: -
Identifier Source: org_study_id
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