Mono Antiplatelet and Colchicine Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Aspirin-free Therapy After Successful Percutaneous Coronary Intervention for Acute Coronary Syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) Pilot Study

Conditions
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Acute Coronary Syndrome, Drug-Eluting Stents

Intervention / Treatment
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* Drug: Aspirin
* Drug: Colchicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mono Antiplatelet and Colchicine Therapy<br>Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment | Drug: Aspirin<br>* Aspirin is discontinued the day after drug-eluting stent implantation<br>* Other names: Aspirin stop;Drug: Colchicine<br>* Colchicine is started the day after drug-eluting stent implantation<br>* Other names: Colchicine start;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes - Definite, probable, and possible stent thrombosis (Academic Research Consortium) | Definite, probable, and possible stent thrombosis (Academic Research Consortium) | Assessed at hospital stay and 30/90 days after stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | Assessed at hospital stay and 30/90 days after stent implantation | 
| Clinical outcomes - All-cause mortality | All-cause mortality | Assessed at hospital stay and 30/90 days after stent implantation | 
| Clinical outcomes - Cardiac and non-cardiac mortality | Cardiac and non-cardiac mortality | Assessed at hospital stay and 30/90 days after stent implantation | 
| Clinical outcomes - All myocardial infarction | All myocardial infarction | 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 | Assessed at hospital stay and 30/90 days after stent implantation | 
| Clinical outcomes - All revascularization | All revascularization | 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 | 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) | Assessed at hospital stay and 30/90 days after stent implantation | 
| Laboratory outcomes - P2Y12 reaction unit | P2Y12 reaction unit using VerifyNow P2Y12 rapid analyzer | Assessed at hospital stay | 
| Laboratory outcomes - Percent platelet inhibition | Percent platelet inhibition using VerifyNow P2Y12 rapid analyzer | Assessed at hospital stay | 
| Laboratory outcomes - C-reactive protein | C-reactive protein | Assessed at hospital stay and 30 days after stent implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet Aggregation Inhibitors, Colchicine