Acute Coronary Syndrome, Drug-Eluting Stents
Conditions
Keywords
Platelet Aggregation Inhibitors, Colchicine
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.
Interventions
DRUGAspirin
Aspirin is discontinued the day after drug-eluting stent implantation
DRUGColchicine
Colchicine is started the day after drug-eluting stent implantation
Sponsors
Wonkwang University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Successful PCI with drug-eluting stent for NSTE-ACS or STEMI * Provision of written informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 - 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 - 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) |
| 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) |
| 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 - All revascularization | Assessed at hospital stay and 30/90 days after stent implantation | All revascularization |
Countries
South Korea
Outcome results
None listed