TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI (NCT03465644) | Clinical Trial Compass
CompletedPhase 4
TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI
South Korea2,018 participantsStarted 2019-02-12
Plain-language summary
This study evaluates the efficacy and safety of tailored antithrombotic therapy with early (\<6-month post-PCI) intensified (low-dose ticagrelor \[120 mg loading, then 60 mg bid maintenance\] and aspirin) and late (\>6-month post-PCI) deescalated (clopidogrel alone) strategy in patients undergoing high-risk complex PCI as compared with standard Dual Antiplatelet Therapy(aspirin and clopidogrel for 12 months).
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
ā. Age 19 and more
ā. Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent
ā. Patients must have at least one of any features of complex high-risk anatomic, procedural, or clinical-related factors;
ā. The patient or guardian agreed to the study protocol and the schedule of clinical follow-up and provided informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.
Exclusion criteria
ā. Enzyme-positive Acute myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST Elevation Myocardial Infarction (STEMI))
ā. Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)
ā. Use of Gp IIb/IIIa inhibitors at randomization
ā. Cardiogenic shock
ā. Treatment with only bare-metal stent (BMS) or balloon angioplasty during the index procedure.
ā. Requirements for chronic oral anticoagulation (warfarin or Non-vitamin K antagonist oral anticoagulant (NOACs))
ā. Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)