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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mono Antiplatelet and Colchicine Therapy | Experimental | Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Aspirin is discontinued the day after drug-eluting stent implantation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Yul Lee, MD | Wonkwang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonkwang University Hospital | Iksan | 54538 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38841588 | Derived | Lee SY, Cho JY, Gorog DA, Angiolillo DJ, Yun KH, Ahn JH, Koh JS, Park Y, Hwang SJ, Hwang JY, Kim JW, Jang Y, Jeong YH. Inflammation and platelet reactivity during adjunctive colchicine versus aspirin in patients with acute coronary syndrome treated with potent P2Y12 inhibitor. Front Med (Lausanne). 2024 Apr 19;11:1349577. doi: 10.3389/fmed.2024.1349577. eCollection 2024. | |
| 37587591 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Colchicine | Drug | Colchicine is started the day after drug-eluting stent implantation |
|
|
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 |
| Derived |
| Lee SY, Jeong YH, Yun KH, Cho JY, Gorog DA, Angiolillo DJ, Kim JW, Jang Y. P2Y12 Inhibitor Monotherapy Combined With Colchicine Following PCI in ACS Patients: The MACT Pilot Study. JACC Cardiovasc Interv. 2023 Aug 14;16(15):1845-1855. doi: 10.1016/j.jcin.2023.05.035. |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |