Ticagrelor De-escalation Strategy in AMI Patients
EASTYLE (DE-escAlation Strategy for Optimal Ticagrelor Therapy in Acute MYocardiaL Infarction PatiEnts, Prospective, Multicenter, Randomized) Trial
Dong-A University
2,312 participants
Mar 27, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria9
- 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.
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Interventions
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 stratetgy indicates conventional DAPT including ticagrelor 90 mg twice daily and aspirin 100 mg once daily during 12 months.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04755387