RECRUITINGPhase 4INTERVENTIONAL

Ticagrelor De-escalation Strategy in AMI Patients

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

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosis with acute myocardial infarction. - Age ≥19 year-old - Successful PCI with ultrathin bioresorbable polymer sirolimus-eluting stents (Orsiro; Biotronik AG). - Provision of willing to sign a consent form. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

De-escalation strategy

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).

DRUG

Conventional strategy

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

Locations (1)

DongA University Hospital

Busan, South Korea