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Ticagrelor De-escalation Strategy in East Asian Patients With AMI

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ClinicalTrials.gov Identifier: NCT04755387
Recruitment Status : Recruiting
First Posted : February 16, 2021
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Moo Hyun Kim, Dong-A University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Ticagrelor 90mg Drug: Ticagrelor 60/45mg Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : February 15, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Ticagrelor

Arms and Interventions
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Arm Intervention/treatment
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 Name: 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 Name: Brilinta 60/45mg


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Primary safety endpoint [ Time Frame: 12 months ]
    Clinically significant bleeding: a composite of major or minor bleeding according to PLATO criteria.


Secondary Outcome Measures :
  1. major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: 12 months ]
    Defined as a composite of cardiac death, myocardial infarction, or stroke

  2. Individual components of MACCE [ Time Frame: 12 months ]
    Indicated cardiac death, myocardial infarction, or stroke

  3. Secondary adverse events [ Time Frame: 12 months ]
    Indicated non-cardiac death, target lesion/vessel revascularization, stent thrombosis.

  4. Major or minor (PLATO) bleeding event [ Time Frame: 12 months ]
    By PLAtelet inhibition and patient Outcomes (PLATO) criteria

  5. Major or minor (TIMI) bleeding event [ Time Frame: 12 months ]
    By the Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria

  6. BARC bleeding from type 1 to 5 [ Time Frame: 12 months ]
    By Bleeding Academic Research Consortium (BARC) definition.

  7. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04755387


Contacts
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Contact: Moo Hyun Kim, M.D. +82-51-240-2976 kimmh@dau.ac.kr
Contact: Cai De Jin, M.D. +8619117712582 jincaide1118@163.com

Locations
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Korea, Republic of
DongA University Hospital Recruiting
Busan, Korea, Republic of, 602-715
Contact: Moo Hyun Kim, M.D.    +82-51-240-2976    kimmh@dau.ac.kr   
Principal Investigator: Moo Hyun Kim, M.D.         
Sponsors and Collaborators
Dong-A University
Investigators
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Principal Investigator: Moo Hyun Kim, M.D. Dong-A University Hospital, Busan, Republic of Korea
More Information
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Publications:

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Responsible Party: Moo Hyun Kim, Professor, Dept. of Cardiology Dong-A University Hospital, Dong-A University
ClinicalTrials.gov Identifier: NCT04755387    
Other Study ID Numbers: EASTYLE
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Moo Hyun Kim, Dong-A University:
Ticagrelor
De-escalation strategy
East Asian
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs