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Acute Myocardial InfarctionPhase 4NCT04755387

Ticagrelor De-escalation Strategy in AMI Patients

A Phase 4 study testing De-escalation strategy and Conventional strategy in people with Acute Myocardial Infarction, run by Dong-A University at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

DAPT de-escalation strategies to reduce bleeding include de-escalation of DAPT intensity (downgrading from potent P2Y12 inhibitor at conventional doses to either clopidogrel or reduced-dose prasugrel) or abbreviation of DAPT duration. Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
De-escalation strategy and Conventional strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,312 participants
Where
1 siteSouth Korea
Study dates
27 Mar 2023to 31 Jan 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis with acute myocardial infarction.
  • Age ≥19 year-old
  • Successful PCI with ultrathin bioresorbable polymer sirolimus-eluting stents (Orsiro; Biotronik AG).
  • Provision of informed consent.

Who cannot join

  • Any prior event of hemorrhagic stroke or ICH.
  • Active bleeding (e.g., GI bleeding, ICH) or high-risk of serious bleeding.
  • Bleeding diathesis or coagulopathy (e.g., hemoglobin ≤ 10 g/dL or platelet count < 100,000/μL, bleeding needing transfusion within 30 days, and so on).
  • Allergy to stent metal, contrat media, and antiplatelet regimens.
  • Moderate to severe hepatic dysfunction (Child-Pugh class B or C).
  • Need for oral anticoagulation therapy.
Show all 9Show fewer
  • Current or potential pregnancy.
  • Currently treated with strong CYP3A4 inhibitors.
  • Life expectancy <1 year.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Moo Hyun Kim, MD, PhD contact

+82-51-240-2976

kimmh@dau.ac.kr

Young-Hoon Jeong, MD, PhD contact

+82-2-2610-6795

goodoctor@naver.com

South Korea1 site, 1 recruiting
  • DongA University Hospital

    Busan, 602-715

    Moo Hyun Kim, M.D., +82-51-240-2976, kimmh@dau.ac.kr

    Moo Hyun Kim, M.D.

    Recruiting

Other trials in South Korea

About this study

Official title: EASTYLE (DE-escAlation Strategy for Optimal Ticagrelor Therapy in Acute MYocardiaL Infarction PatiEnts, Prospective, Multicenter, Randomized) Trial

DAPT de-escalation strategies to reduce bleeding include de-escalation of DAPT intensity (downgrading from potent P2Y12 inhibitor at conventional doses to either clopidogrel or reduced-dose prasugrel) or abbreviation of DAPT duration. The EASTYLE trial will evaluate a hybrid DAPT de-escalation strategy (reduced-dose ticagrelor, followed by aspirin early discontinuation) in AMI patients, compared with a conventional DAPT strategy.

Read the detailed description

In ACS patients undergoing percutaneous coronary intervention, conventional dual antiplatelet therapy (DAPT) for patients with acute coronary syndromes undergoing percutaneous coronary intervention comprises aspirin with a potent P2Y12 inhibitor (prasugrel or ticagrelor) for 12 months. Although this approach reduces ischaemic risk, patients are exposed to a substantial risk of bleeding during the stabilized period. Strategies to reduce bleeding include de-escalation of DAPT intensity (downgrading from potent P2Y12 inhibitor at conventional doses to either clopidogrel or reduced-dose prasugrel) or abbreviation of DAPT duration. Abbreviation of DAPT duration after 1-6 months, followed by monotherapy with aspirin or a P2Y12 inhibitor, reduces bleeding without an increase in ischaemic events in patients at high bleeding risk, particularly those without high ischaemic risk. Either strategy requires assessment of the ischaemic and bleeding risks of each individual. Previous clinical and laboratory evidence demonstrates that a conventional-dose of ticagrelor has a potent antiplatelet effect, which appears to have a potential to increase the risk of bleeding during the stabilized period. Adjunctive use of aspirin to P2Y12 inhibitor would be important to protect the risk of thrombotic events in AMI patients, which use has a limited benefit with increased bleeding rate during the the stabilized period.

The EASTYLE trial will evaluate clinical benefit of step-down de-escalation DAPT strategy including downgrading of P2Y12 inhibition (from 90 mg to 60 mg ticagrelor at 1 month post-PCI) and abbreviation of DAPT duration (aspirin discontinuation at 3 months post-PCI), compared with a conventional DAPT strategy in AMI patients. This trial will support that the optimal platelet inhibition would be attenuated over time even in AMI patients. The result will make a big step toward precision medicine in the field of antiplatelet treatment in AMI patients.

Being tested
De-escalation strategy, Conventional strategy
Keywords
Ticagrelor, DAPT, De-escalation strategy, Abbreviated strategy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • De-escalation strategyDrug

    Also called Ticagrelor 60 mg, aspirin early discontinuation

    De-escalation strategy indicates conventional DAPT (ticagrelor 90 mg twice daily + aspirin 100 mg once daily) for 1 month, followed by de-escalation DAPT (ticagrelor 60 mg twice daily + aspirin 100 mg once daily) between 1 and 3 months. Between 3 and 12 months, patients will be treated with ticagrelor monotherapy (ticagrelor 60 mg twice daily).

  • Conventional strategyDrug

    Also called Ticagrelor 90 mg, DAPT

    Conventional stratetgy indicates conventional DAPT including ticagrelor 90 mg twice daily and aspirin 100 mg once daily during 12 months.

Study groups in NCT04755387
Study groupRoleWhat they receive
De-escalation strategyExperimentalPCI ~ 1 month: ticagrelor 90 mg twice daily + aspirin 100 mg once daily 1 ~ 3 months: ticagrelor 60 mg twice daily + aspirin 100 mg once daily 3 ~ 12 months: ticagrelor 60 mg twice daily
Receives: Drug: De-escalation strategy
Conventional strategyActive comparatorPCI ~ 12 months: ticagrelor 90 mg twice daily + aspirin 100 mg once daily
Receives: Drug: Conventional strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary endpoint (NACE)

    MACCE (all-cause death, non-fatal myocardial infarction, stent thrombosis or non-fatal stroke) + major bleeding (BARC type 2, 3, or 5 bleeding)

    Measured: 12 months

Secondary outcomes (13)
  1. Major adverse cardiac and cerebrovascular events (MACCE)

    all-cause death, non-fatal myocardial infarction, stent thrombosis or non-fatal stroke

    Measured: 12 months

  2. Bleeding events

    BARC type 2, 3 or 5 bleeding; BARC 3 or 5 bleeding; TIMI major or minor bleeding; GUSTO severe or moderate bleeding; ISTH major bleeding

    Measured: 12 months

  3. All-cause death

    any mortality

    Measured: 12 months

  4. CV death

    Death related CV system

    Measured: 12 months

  5. MI

    Myocardial infarction

    Measured: 12 months

  6. Stent thrombosis

    definite or probable stent thrombosis by Academic Research Consortium (ARC) definition

    Measured: 12 months

  7. Ischemic stroke

    Stroke

    Measured: 12 months

  8. Cardiac death, or MI

    Coronary thrombotic events

    Measured: 12 months

  9. Cardiac death, MI or stent thrombosis

    Coronary thrombotic events

    Measured: 12 months

  10. Cardiovascular death, MI or stroke

    MACE

    Measured: 12 months

  11. TLR

    target lesion revascularization

    Measured: 12 months

  12. TVR

    target vessel revascularization

    Measured: 12 months

  13. Any revascularization

    Re-PCI during follow-up

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2021
  2. Study start27 Mar 2023
  3. Primary completion15 Jan 2027 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,312 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04755387
Sponsor's protocol ID
EASTYLE
Status last verified
Sep 2025
First submitted
11 Feb 2021
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Goto S, Huang CH, Park SJ, Emanuelsson H, Kimura T. Ticagrelor vs. clopidogrel in Japanese, Korean and Taiwanese patients with acute coronary syndrome -- randomized, double-blind, phase III PHILO study. Circ J. 2015;79(11):2452-60. doi: 10.1253/circj.CJ-15-0112. Epub 2015 Sep 16.

    PubMed 26376600
  • Jin C, Kim MH, Bang J, Serebruany V. A Prospective, Randomized, Open-Label, Blinded, Endpoint Study Exploring Platelet Response to Half-Dose Prasugrel and Ticagrelor in Patients with the Acute Coronary Syndrome: HOPE-TAILOR Study. Cardiology. 2017;138(4):201-206. doi: 10.1159/000478000. Epub 2017 Aug 16.

    PubMed 28810251
  • Gorog DA, Ferreiro JL, Ahrens I, Ako J, Geisler T, Halvorsen S, Huber K, Jeong YH, Navarese EP, Rubboli A, Sibbing D, Siller-Matula JM, Storey RF, Tan JWC, Ten Berg JM, Valgimigli M, Vandenbriele C, Lip GYH. De-escalation or abbreviation of dual antiplatelet therapy in acute coronary syndromes and percutaneous coronary intervention: a Consensus Statement from an international expert panel on coronary thrombosis. Nat Rev Cardiol. 2023 Dec;20(12):830-844. doi: 10.1038/s41569-023-00901-2. Epub 2023 Jul 20.

    PubMed 37474795
  • Gorog DA, Jeyalan V, Markides RIL, Navarese EP, Jeong YH, Farag M. Comparison of De-escalation of DAPT Intensity or Duration in East Asian and Western Patients with ACS Undergoing PCI: A Systematic Review and Meta-analysis. Thromb Haemost. 2023 Aug;123(8):773-792. doi: 10.1055/s-0043-57030. Epub 2023 Apr 18.

    PubMed 37072035
  • Kang MG, Ahn JH, Kim K, Koh JS, Park JR, Hwang SJ, Park Y, Tantry US, Gurbel PA, Hwang JY, Jeong YH. Prevalence of adverse events during ticagrelor versus clopidogrel treatment and its association with premature discontinuation of dual antiplatelet therapy in East Asian patients with acute coronary syndrome. Front Cardiovasc Med. 2022 Dec 12;9:1053867. doi: 10.3389/fcvm.2022.1053867. eCollection 2022.

    PubMed 36578832
  • Kubica J, Adamski P, Gorog DA, Kubica A, Jilma B, Budaj A, Siller-Matula JM, Gurbel PA, Alexopoulos D, Badariene J, Dabrowski P, Dudek D, Giannitsis E, Horszczaruk G, Jaguszewski MJ, James S, Jeong YH, Kryjak M, Niezgoda P, Ostrowska M, Patti G, Romanek J, Di Somma S, Specchia G, Tantry U, Gasior M, Tycinska A, Wojakowski W, Buszko K, Gil R, Gruchala M, Kasprzak J, Kleinrok A, Legutko J, Lesiak M, Navarese EP. Low-dose ticagrelor with or without acetylsalicylic acid in patients with acute coronary syndrome: Rationale and design of the ELECTRA-SIRIO 2 trial. Cardiol J. 2022;29(1):148-153. doi: 10.5603/CJ.a2021.0118. Epub 2021 Oct 8. No abstract available.

    PubMed 34622433
  • Kim L, Choe JC, Ahn JH, Lee HW, Oh JH, Choi JH, Lee HC, Cha KS, Hong TJ, Jeong YH, Park JS. Temporal Trends of Bleeding Episodes during Half- vs. Standard-Dose Ticagrelor in Acute Coronary Syndrome Patients with Low Platelet Reactivity: A Randomized BLEEDING-ACS Trial. J Clin Med. 2021 Mar 10;10(6):1159. doi: 10.3390/jcm10061159.

    PubMed 33802015
  • Kim HK, Tantry US, Smith SC Jr, Jeong MH, Park SJ, Kim MH, Lim DS, Shin ES, Park DW, Huo Y, Chen SL, Bo Z, Goto S, Kimura T, Yasuda S, Chen WJ, Chan M, Aradi D, Geisler T, Gorog DA, Sibbing D, Lip GYH, Angiolillo DJ, Gurbel PA, Jeong YH. The East Asian Paradox: An Updated Position Statement on the Challenges to the Current Antithrombotic Strategy in Patients with Cardiovascular Disease. Thromb Haemost. 2021 Apr;121(4):422-432. doi: 10.1055/s-0040-1718729. Epub 2020 Nov 10.

    PubMed 33171520
  • Park Y, Koh JS, Lee JH, Park JH, Shin ES, Oh JH, Chun W, Lee SY, Bae JW, Kim JS, Kim W, Suh JW, Yang DH, Hong YJ, Chan MY, Kang MG, Park HW, Hwang SJ, Hwang JY, Ahn JH, Choi SW, Jeong YH; HEALING-AMI Investigators. Effect of Ticagrelor on Left Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction (HEALING-AMI). JACC Cardiovasc Interv. 2020 Oct 12;13(19):2220-2234. doi: 10.1016/j.jcin.2020.08.007.

    PubMed 33032710

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing De-escalation strategy and Conventional strategy in people with Acute Myocardial Infarction, run by Dong-A University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Moo Hyun Kim, MD, PhD (+82-51-240-2976, kimmh@dau.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary endpoint (NACE) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04755387, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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