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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,018
Low-dose (60mg) ticagrelor + aspirin for 6months and then clopidogrel alone for 6months
Clopidogrel + aspirin for 12months
Hallym University Sacred Heart Hospital
Anyang, South Korea
Soon Chun Hyang University Hospital Bucheon
Net clinical outcome
a net clinical outcome of all-cause death, myocardial infarction, stroke, stent thrombosis, urgent revascularization or clinically relevant bleeding \[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\] at 12 months after randomisation
Time frame: 1 year
Death
Efficacy outcomes: any, cardiovascular, or non-cardiovascular cause death
Time frame: 1 year
Myocardial infarction
Efficacy outcomes: any, periprocedural, or spontaneous Myocardial infarction
Time frame: 1 year
Stroke
Efficacy outcomes: any, ischemic, or hemorrhagic Stroke
Time frame: 1 year
Stent thrombosis
Efficacy outcomes
Time frame: 1 year
The rate of unplanned urgent repeat revascularization
Efficacy outcomes: any, target-vessel, or non-target-vessel Repeat revascularisation
Time frame: 1 year
Composite of ischemic clinical endpoints (all-cause death, myocardial infarction, stroke, stent thrombosis, or urgent revascularization)
Efficacy outcomes
Time frame: 1 year
Composite of hard clinical endpoints (all-caused death, myocardial infarction, or stroke)
Efficacy outcomes
Time frame: 1 year
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Bucheon-si, South Korea
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Chungbuk National University Hospital
Cheonju, South Korea
Gangwon National Univ. Hospital
Chuncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Dong-A Medical Center
Pusan, South Korea
...and 12 more locations
BARC major bleeding (type 3 or 5 bleeding)
Safety outcomes: Bleeding Academic Research Consortium
Time frame: 1 year
TIMI major or minor bleeding
Safety outcomes: Thrombolysis In Myocardial Infarction
Time frame: 1 year
GUSTO moderate or severe bleeding
Safety outcomes: Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries
Time frame: 1 year
ISTH major bleeding
Safety outcomes: International Society of Thrombosis and Hemostasis; PCI, percutaneous coronary intervention
Time frame: 1 year
Any major or minor bleeding
Safety outcomes
Time frame: 1 year