Ticagrelor De-escalation Strategy in East Asian Patients With AMI

February 11, 2021 updated by: Moo Hyun Kim, Dong-A University

A Prospective, Randomized, Open-Label, Multicenter Study Assessing Efficacy and Safety of Ticagrelor De-escalation Strategy in East Asian Acute Myocardial Infarction With Coronary Intervention: EASTYLE Trial

Ticagrelor as nonthienopyridine, direct-acting P2Y12 receptor antagonist, had significantly greater platelet inhibition, which could reduce ischemic events at acute phase, however, resulting in more incidence of bleedings than pro-drug P2Y12 receptor inhibitor during chronic phase for management of acute myocardial infarction (AMI) following percutaneous coronary intervention (PCI). Also, East Asians have higher response to potent agent, like ticagrelor, when compared with Caucasians. With this in mind, East Asian patients will be required optimal, potentially reduced dose of ticagrelor to improve the safety profile, maintaining better vascular outcomes. Similarly, there are insufficient East Asian data on the efficacy and safety of low-dose ticagrelor in real-word practice. Whether the de-escalation strategy (ticagrelor 60/45 mg twice daily) are more adequate for clinical practice in East Asian is unclear. Therefore, the investigators design the EASTYLE study, hypothesis that low-dose ticagrelor would be more likely adequate for optimal antiplatelet treatment without increasing ischemic and bleeding events in East Asian with AMI compared with standard-dose ticagrelor. In the EASTYLE trial, further clinical data of de-escalation strategy guided AMI management in East Asian will be provided.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In EASTYLE trial, the investigators aim to evaluate the efficacy and safety of de-escalation strategy ticagrelor (60/45 mg twice daily), as compared with standard strategy ticagrelor (90 mg twice daily) in East Asian patients with AMI undergoing PCI.

All eligible AMI patients receive loading dose of ticagrelor 180 mg plus aspirin 300 mg, following ticagrelor 90 mg twice daily plus aspirin 100 mg daily during the index hospitalization. Subsequently, to be randomly assigned into ticagrelor 90 mg and ticagrelor 60/45 mg twice daily in combination with aspirin 100 mg daily at discharge for at least 12-month period treatment.

The investigators focusing on the efficacy and safety endpoint, is net adverse clinical and cerebrovascular events (NACCE), composite of all-cause mortality, myocardial infarction, stroke, and major bleeding.

Study Type

Interventional

Enrollment (Anticipated)

2000

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, M.D.
  • Phone Number: +82-51-240-2976
  • Email: kimmh@dau.ac.kr

Study Contact Backup

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 80 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 receive potent DAPT (Ticagrelor 180 mg loading dose followed by 90 mg twice daily plus Aspirin 300 mg loading dose followed by 100 mg daily).
  • Patients provide written informed consent prior to enrollment.

Exclusion Criteria:

  • History of transient ischemic attack or stroke.
  • History of upper gastrointestinal bleeding in recent 6 months.
  • Renal dysfunction defined as serum creatinine > 2.5 mg/dl.
  • Severe hepatic dysfunction defined as serum transaminase > 3 times normal limit.
  • On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
  • Bleeding tendency.
  • Thrombocytopenia defined by platelet < 100,000/ml.
  • Anemia defined by hemoglobin < 10 g/dl.
  • 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.
  • Known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (SSS) or high degree AV block without pacemaker protection).
  • Contraindication for study drugs.

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
Other: Ticagrelor 90mg
Standard strategy group receive ticagrelor 90mg twice daily
Drug: Ticagrelor 90mg
Standard strategy initially receive ticagrelor 90mg twice daily for 12 months.
Other Names:
  • Brilinta 90mg
Experimental: Ticagrelor 60/45mg
De-escalation strategy group receive ticagrelor 60 mg twice daily or 45mg twice daily if patients with body weight <60kg, or age >75 years old.
Drug: Ticagrelor 60/45mg
In-hospital treatment with standard strategy ticagrelor 90mg twice daily, following de-escalation strategy ticagrelor 60/45mg twice daily after discharge for 12 months.
Other Names:
  • Brilinta 60/45mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Net adverse clinical and cerebral events (NACCE)
Time Frame: 12 months
Composite of all-cause death, myocardial infarction, stroke or major bleeding according to PLATO criteria.
12 months
Primary safety endpoint
Time Frame: 12 months
Clinically significant bleeding: a composite of major or minor bleeding according to PLATO criteria.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major adverse cardiac and cerebrovascular events (MACCE)
Time Frame: 12 months
Defined as a composite of cardiac death, myocardial infarction, or stroke
12 months
Individual components of MACCE
Time Frame: 12 months
Indicated cardiac death, myocardial infarction, or stroke
12 months
Secondary adverse events
Time Frame: 12 months
Indicated non-cardiac death, target lesion/vessel revascularization, stent thrombosis.
12 months
Major or minor (PLATO) bleeding event
Time Frame: 12 months
By PLAtelet inhibition and patient Outcomes (PLATO) criteria
12 months
Major or minor (TIMI) bleeding event
Time Frame: 12 months
By the Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria
12 months
BARC bleeding from type 1 to 5
Time Frame: 12 months
By Bleeding Academic Research Consortium (BARC) definition.
12 months
Premature discontinuation of study drugs
Time Frame: 12 months
The patients cannot tolerate to be continued study drugs, due to bleeding event, or side effect.
12 months

Collaborators and Investigators

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

Sponsor

Dong-A University

Investigators

  • Principal Investigator: Moo Hyun Kim, M.D., Dong-A University Hospital, Busan, Republic of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

February 15, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EASTYLE

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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