Ticagrelor De-escalation Strategy in AMI Patients
ConditionAcute Myocardial Infarction
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19-80
SponsorDong-A University
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- De-escalation strategy
- Conventional strategy
Treatment groups
2,312 Participants
are divided into 2 treatment groupsSponsors and collaborators
Dong-A University
Lead sponsor
Biotronik SE & Co. KG
Collaborator
Samjin Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov