Mono Antiplatelet and Colchicine Therapy
- Conditions
- Acute Coronary SyndromeDrug-Eluting Stents
- Interventions
- Registration Number
- NCT04949516
- Lead Sponsor
- Wonkwang University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Successful PCI with drug-eluting stent for NSTE-ACS or STEMI
- Provision of written informed consent
- Cardiac arrest or cardiogenic shock
- Age <19 or >90 years old
- Severe liver impairment
- Severe renal impairment (eGFR <30 mL/min/1.73 m2)
- Atrial fibrillation requiring anticoagulation therapy
- Intolerance of prasugrel, ticagrelor, or colchicine
- History of intracranial hemorrhage
- Active bleeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mono Antiplatelet and Colchicine Therapy Aspirin Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment Mono Antiplatelet and Colchicine Therapy Colchicine Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment
- Primary Outcome Measures
Name Time Method Clinical outcomes - Definite, probable, and possible stent thrombosis (Academic Research Consortium) Assessed at hospital stay and 30/90 days after stent implantation Definite, probable, and possible stent thrombosis (Academic Research Consortium)
- Secondary Outcome Measures
Name Time Method Clinical outcomes - TV-MI and non-TV-MI Assessed at hospital stay and 30/90 days after stent implantation TV-MI and non-TV-MI
Clinical outcomes - All revascularization Assessed at hospital stay and 30/90 days after stent implantation All revascularization
Clinical outcomes - Target vessel failure Assessed at hospital stay and 30/90 days after stent implantation Composite time-to-first event rate of cardiac death, target vessel-myocardial infarction (TV-MI), or ischemia driven-target vessel revascularization (ID-TVR)
Laboratory outcomes - P2Y12 reaction unit Assessed at hospital stay P2Y12 reaction unit using VerifyNow P2Y12 rapid analyzer
Laboratory outcomes - Percent platelet inhibition Assessed at hospital stay Percent platelet inhibition using VerifyNow P2Y12 rapid analyzer
Laboratory outcomes - C-reactive protein Assessed at hospital stay and 30 days after stent implantation C-reactive protein
Clinical outcomes - Target lesion failure Assessed at hospital stay and 30/90 days after stent implantation Composite time-to-first event rate of cardiac death, TV-MI, or ischemia driven-target lesion revascularization (ID-TLR)
Clinical outcomes - All-cause mortality Assessed at hospital stay and 30/90 days after stent implantation All-cause mortality
Clinical outcomes - Cardiac and non-cardiac mortality Assessed at hospital stay and 30/90 days after stent implantation Cardiac and non-cardiac mortality
Clinical outcomes - All myocardial infarction Assessed at hospital stay and 30/90 days after stent implantation All myocardial infarction
Clinical outcomes - ID-TVR, ID-TLR and ID-non-TLR TVR Assessed at hospital stay and 30/90 days after stent implantation ID-TVR, ID-TLR and ID-non-TLR TVR
Clinical outcomes - Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium) Assessed at hospital stay and 30/90 days after stent implantation Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)
Trial Locations
- Locations (1)
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of