Status:
RECRUITING
Ticagrelor De-escalation Strategy in AMI Patients
Lead Sponsor:
Dong-A University
Collaborating Sponsors:
Biotronik SE & Co. KG
Samjin Pharmaceutical Co., Ltd.
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
19-80 years
Phase:
PHASE4
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)...
Detailed Description
In ACS patients undergoing percutaneous coronary intervention, conventional dual antiplatelet therapy (DAPT) for patients with acute coronary syndromes undergoing percutaneous coronary intervention co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2028
Estimated Enrollment :
2312 Patients enrolled
Trial Details
Trial ID
NCT04755387
Start Date
March 27 2023
End Date
January 31 2028
Last Update
October 1 2025
Active Locations (1)
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1
DongA University Hospital
Busan, South Korea, 602-715