Optimal Dosage of Ticagrelor in Korean Patients With AMI

January 14, 2022 updated by: Moo Hyun Kim, Dong-A University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Moo Hyun Kim, MD
  • Phone Number: +82-51-240-2976
  • Email: kimmh@dau.ac.kr

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Recruiting
        • DongA University Hospital
        • Contact:
        • Principal Investigator:
          • Moo Hyun Kim, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimal platelet reactivity (OPR) rate
Time Frame: At 1 month
OPR, indicate 85 to 208 for P2Y12 reaction units (PRU)
At 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac and cerebrovascular events (MACCE)
Time Frame: At 9 months
MACCE: composite of cardiac death, non-fatal myocardial infarction, target lesion / vessel revascularization and stroke
At 9 months
Bleeding events
Time Frame: At 9 months.
BARC: Bleeding Academic Research Consortium (BARC ≥2).
At 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOPE-TAILOR 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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