The purpose of this prospective randomized clinical trial is to compare the clinical outcomes according to the duration of aspirin and clopidogrel or prasugrel with dual anti-platelet therapy after percutaneous coronary intervention in patients with advanced chronic kidney disease using a new generation drug eluting stents.
Prospective, open label, multicenter randomized clinical trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
900
Patients enrolled in dual antiplatelets at least 6 months arm would be administered with aspirin 100mg plus clopidogrel 75mg or prasugrel 10mg once daily for at least 6 months after randomization. Clopidogrel or prasugrel should be maintained after 6 months.
Patient enrolled in the dual antiplatelet therapy less than 3 months arm would be administered with aspirin 100mg plus clopidogrel 75mg or prasugrel 10mg once daily for less than 3 months after randomization. After 3 months clopidogrel or prasugrel should be maintained.
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea
RECRUITINGNet Clinical adverse event (NACE)
A composite of all cause death, myocardial infarction, stent thrombosis, stroke, major bleeding (BARC 3,5)
Time frame: 1 year
The rate of Each component of NACE
all cause death, myocardial infarction, stent thrombosis, stroke, major bleeding (BARC 3,5)
Time frame: 1 year
The rate of Cardiovascular death
Time frame: 1 year
The rate of Major adverse cardiovascular events (MACE)
A composite of cardiovascular death, myocardial infarction, stent thrombosis or target vessel revascularization
Time frame: 1 year
The rate of Composite ischemic outcomes
A composite of cardiovascular death, myocardial infarction, stent thrombosis or ischemic stroke
Time frame: 1 year
The rate of major or clinically relevant nonmajor bleeding
BARC type 2,3,5 bleeding
Time frame: 1 year
Fatal bleeding
Time frame: 1 year
Intracranial hemorrhage
Time frame: 1 year
The rate of Target lesion revascularization
Time frame: 1 year
The rate of Target vessel revascularization
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Time frame: 1 year
The rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the CKD stage (lllb vs. IV or V)
Time frame: 1 year
The rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the clinical presentation (chronic coronary syndrome vs. acute coronary syndrome)
Time frame: 1 year
he rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the type of Stent (polymer-free vs. durable-polymer)
Time frame: 1 year