This study is an open label, multi-center, randomized trial, which is designed to evaluate the efficacy and safety of clopidogrel derivative (Pregrel®) therapy for 12 months in patients undergoing PCI compared to conventional clopidogrel (Plavix®).
Prospective, two arms, randomized multi-center trial of 1,056 patients enrolled at 3 centers in Korea. Following angiography, patients with significant diameter stenosis \>50% by visual estimation have documented myocardial ischemia or symptoms of angina and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Pregrel® group vs. b) Plavix®. This trial is the non-inferiority study to demonstrate that the incidence of 12 months primary end-point in Pregrel® group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,056
Gangneung Asan Hospital
Gangneung, South Korea
Asan Medical Center
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke
Time frame: 12 months
composite of death, MI, stroke, or urgent revascularization
Time frame: 12 months
Individual components of death, MI, stroke, or urgent revascularization
Time frame: at discharge
The need for target vessel revascularization or any revascularization
Time frame: 12 months
The incidence of early discontinuation of study drugs
Time frame: 30 days
The incidence of major bleeding events
Time frame: 30 days
Stent thrombosis
Time frame: 30 days
composite of death, MI, stroke, or urgent revascularization
Time frame: 30 days
composite of death, MI, stroke, or urgent revascularization
Time frame: 6 months
Individual components of death, MI, stroke, or urgent revascularization
Time frame: 30 days
Individual components of death, MI, stroke, or urgent revascularization
Time frame: 6 months
Individual components of death, MI, stroke, or urgent revascularization
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Time frame: 12 months
The incidence of major bleeding events
Time frame: 6 months
The incidence of major bleeding events
Time frame: 12 months
The incidence of early discontinuation of study drugs
Time frame: 6 months
The incidence of early discontinuation of study drugs
Time frame: 12 months
Stent thrombosis
Time frame: 6 months
Stent thrombosis
Time frame: 12 months