Reduced-dose ticagrelor with early aspirin discontinuation after PCI for acute myocardial infarction
Official title: EASTYLE (DE-escAlation Strategy for Optimal Ticagrelor Therapy in Acute MYocardiaL Infarction PatiEnts, Prospective, Multicenter, Randomized) Trial
Run by Dong-A University · NCT04755387 · Data updated 2026-11-12
This trial will see if switching to reduced‑dose ticagrelor and stopping aspirin early lowers bleeding without increasing clots in adults with acute myocardial infarction treated with Orsiro stents.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Enrollment | 2312 (estimated) |
| Sponsor | Dong-A University Academic / other |
| Locations | 1 site (Busan) |
| Status | Recruiting |
| Started | March 27, 2023 |
| Main results expected | January 15, 2027 |
| Study ends | January 31, 2028 |
| Registry record updated | October 1, 2025 |
| Trial ID | NCT04755387 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥19) with acute myocardial infarction who had successful PCI with an Orsiro stent and can provide informed consent are the intended candidates.
✕Probably not a fit
Patients who require oral anticoagulation, have recent major bleeding or prior hemorrhagic stroke, severe hepatic dysfunction, or a life expectancy under one year are unlikely to benefit and are generally excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial compares a hybrid de‑escalation dual antiplatelet strategy—reduced‑dose ticagrelor followed by early aspirin discontinuation—with a conventional 12‑month DAPT regimen in patients with acute myocardial infarction who underwent successful PCI with Orsiro ultrathin bioresorbable polymer sirolimus‑eluting stents. Eligible participants are adults (≥19 years) able to give informed consent; key exclusions include prior hemorrhagic stroke, active high‑risk bleeding, need for oral anticoagulation, severe hepatic dysfunction, or life expectancy under one year. Patients will be followed for clinical outcomes including bleeding and ischaemic events to compare safety and effectiveness between strategies. The trial is sponsored by Dong‑A University and conducted at Dong‑A University Hospital in Busan, South Korea.
Why it matters
Potential benefit: If successful, the approach could reduce bleeding complications after heart attack while preserving protection against stent thrombosis and other ischaemic events.
How similar studies have gone: Prior trials of either de‑escalating DAPT intensity or shortening DAPT duration have reduced bleeding without increasing ischaemic events in selected patients, though the specific hybrid reduced‑dose ticagrelor plus early aspirin‑stop strategy is less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
-
DongA University Hospital
Busan, South Korea Recruiting
Study contacts
- Principal investigator: Moo Hyun Kim, MD, PhD — Dong-A University Hospital, Busan, Republic of Korea
- Study coordinator: Moo Hyun Kim, MD, PhD
- Email: kimmh@dau.ac.kr
- Phone: +82-51-240-2976
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.