NCT04755387

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,312

participants targeted

Target at P75+ for phase_4

Timeline
21mo left

Started Mar 2023

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress64%
Mar 2023Jan 2028

First Submitted

Initial submission to the registry

February 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
2.1 years until next milestone

Study Start

First participant enrolled

March 27, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

3.8 years

First QC Date

February 11, 2021

Last Update Submit

September 26, 2025

Conditions

Acute Myocardial Infarction

Keywords

TicagrelorDAPTDe-escalation strategyAbbreviated strategy

Outcome Measures

Primary Outcomes (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)

    12 months

Secondary Outcomes (13)

  • Major adverse cardiac and cerebrovascular events (MACCE)

    12 months

  • Bleeding events

    12 months

  • All-cause death

    12 months

  • CV death

    12 months

  • MI

    12 months

  • +8 more secondary outcomes

Other Outcomes (15)

  • Type of AMI

    12 months

  • HBR

    12 months

  • DM

    12 months

  • +12 more other outcomes

Study Arms (2)

De-escalation strategy

EXPERIMENTAL

PCI \~ 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

Drug: De-escalation strategy

Conventional strategy

ACTIVE COMPARATOR

PCI \~ 12 months: ticagrelor 90 mg twice daily + aspirin 100 mg once daily

Drug: Conventional strategy

Interventions

De-escalation strategyDRUG

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).

Also known as: Ticagrelor 60 mg, aspirin early discontinuation
De-escalation strategy
Conventional strategyDRUG

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

Also known as: Ticagrelor 90 mg, DAPT
Conventional strategy

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Current or potential pregnancy.
  • Currently treated with strong CYP3A4 inhibitors.
  • Life expectancy \<1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DongA University Hospital

Busan, 602-715, South Korea

RECRUITING

Related Publications (9)

  • 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.

    PMID: 26376600BACKGROUND

  • 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.

    PMID: 28810251BACKGROUND

  • 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.

    PMID: 37474795BACKGROUND

  • 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.

    PMID: 37072035BACKGROUND

  • 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.

    PMID: 36578832BACKGROUND

  • 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.

    PMID: 34622433BACKGROUND

  • 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.

    PMID: 33802015BACKGROUND

  • 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.

    PMID: 33171520BACKGROUND

  • 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.

    PMID: 33032710BACKGROUND

MeSH Terms

Interventions

Ticagrelor2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Moo Hyun Kim, MD, PhD

    Dong-A University Hospital, Busan, Republic of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moo Hyun Kim, MD, PhD

CONTACT

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

Young-Hoon Jeong, MD, PhD

CONTACT

+82-2-2610-6795goodoctor@naver.com

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, Deptartment of Cardiology, Dong-A University Hospital

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 16, 2021

Study Start

March 27, 2023

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations

KR(1)