NCT05210595

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

January 14, 2022

Last Update Submit

January 14, 2022

Conditions

Acute Myocardial InfarctionTicagrelor

Keywords

TicagrelorDe-escalation StrategyKorean

Outcome Measures

Primary Outcomes (1)

  • Optimal platelet reactivity (OPR) rate

    OPR, indicate 85 to 208 for P2Y12 reaction units (PRU)

    At 1 month

Secondary Outcomes (2)

  • Major adverse cardiac and cerebrovascular events (MACCE)

    At 9 months

  • Bleeding events

    At 9 months.

Study Arms (3)

Control group

EXPERIMENTAL

Clopidogrel 75 mg/day as maintenance dose

Drug: Clopidogrel 75 mg

Treatment group 1

EXPERIMENTAL

De-escalation strategy dose receive ticagrelor 60 mg twice daily

Drug: Ticagrelor 60mg

Treatment group 2

EXPERIMENTAL

De-escalation strategy dose receive ticagrelor 45 mg twice daily

Drug: Ticagrelor 45 mg

Interventions

Clopidogrel 75 mgDRUG

75 mg/day as maintenance dose.

Also known as: Plavix 75 mg
Control group
Ticagrelor 60mgDRUG

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.

Also known as: Brilinta 60 mg
Treatment group 1
Ticagrelor 45 mgDRUG

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 .

Also known as: Brilinta 45 mg
Treatment group 2

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DongA University Hospital

Busan, 602-715, South Korea

RECRUITING

MeSH Terms

Interventions

ClopidogrelTicagrelor

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAdenosinePurine NucleosidesPurinesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Moo Hyun Kim, MD

    Dong-A University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moo Hyun Kim, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Dept. of Cardiology Dong-A University Hospital

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 27, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

January 27, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)