The purpose of this study is to evaluate the efficacy and safety of aspirin-free, P2Y12 inhibitor single antiplatelet and colchicine treatment in patients with acute coronary syndrome treated with drug-eluting stents.
After successful drug-eluting stent implantation for acute coronary syndrome, screening for study subject enrollment is performed. For those who submitted written informed consent, aspirin is stopped the day after the intervention, and colchicine 0.6mg once daily is started. The P2Y12 inhibitor, prasugrel or ticagrelor, for single antiplatelet therapy remains. For the duration of hospital stay, platelet reactivity using VerifyNow test and C-reactive protein are measured. Aspirin may be restarted at the discretion of the investigator based on results of the platelet function test. C-reactive protein is remeasured 30 days after the intervention. Clinical follow-up is performed 30 days and 90 days after the intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Aspirin is discontinued the day after drug-eluting stent implantation
Colchicine is started the day after drug-eluting stent implantation
Wonkwang University Hospital
Iksan, South Korea
Clinical outcomes - Definite, probable, and possible stent thrombosis (Academic Research Consortium)
Definite, probable, and possible stent thrombosis (Academic Research Consortium)
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - Target vessel failure
Composite time-to-first event rate of cardiac death, target vessel-myocardial infarction (TV-MI), or ischemia driven-target vessel revascularization (ID-TVR)
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - Target lesion failure
Composite time-to-first event rate of cardiac death, TV-MI, or ischemia driven-target lesion revascularization (ID-TLR)
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - All-cause mortality
All-cause mortality
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - Cardiac and non-cardiac mortality
Cardiac and non-cardiac mortality
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - All myocardial infarction
All myocardial infarction
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - TV-MI and non-TV-MI
TV-MI and non-TV-MI
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
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Clinical outcomes - All revascularization
All revascularization
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - ID-TVR, ID-TLR and ID-non-TLR TVR
ID-TVR, ID-TLR and ID-non-TLR TVR
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)
Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Laboratory outcomes - P2Y12 reaction unit
P2Y12 reaction unit using VerifyNow P2Y12 rapid analyzer
Time frame: Assessed at hospital stay
Laboratory outcomes - Percent platelet inhibition
Percent platelet inhibition using VerifyNow P2Y12 rapid analyzer
Time frame: Assessed at hospital stay
Laboratory outcomes - C-reactive protein
C-reactive protein
Time frame: Assessed at hospital stay and 30 days after stent implantation