Acute Coronary Syndrome
Conditions
Keywords
Colchicine
Brief summary
The previous Mono Antiplatelet and Colchicine Therapy (MACT) pilot study (NCT04949516) demonstrated that it was feasible to discontinue aspirin therapy and administer low-dose colchicine on the day after percutaneous coronary intervention (PCI) in addition to potent P2Y12 inhibitors in patients with acute coronary syndrome (ACS). However, the efficacy and safety of MACT have not yet been investigated. The goal of this clinical trial is to evaluate the clinical outcomes of ticagrelor P2Y12 inhibitor monotherapy combined with colchicine immediately after PCI in patients with ACS. The main questions it aims to answer are: * What is the frequency of the composite endpoint of cardiovascular death, nonfatal spontaneous myocardial infarction, nonfatal ischemic stroke, unplanned hospitalization leading to urgent revascularization, and major bleeding at 12 months post-intervention? * What is the frequency of stent thrombosis at 12 months post-intervention? For pre-specified analyses, researchers will compare MACT to less than 1 month, 3-month, and 12-month dual antiplatelet therapy (individual patient data from the T-PASS \[NCT03797651\] and TICO \[NCT02494895\] trials) to determine if MACT is effective in treating ACS. Participants will: * Take low-dose colchicine in addition to ticagrelor maintenance therapy, discontinuing aspirin the day after PCI. * Take a high-sensitivity C-reactive protein (hs-CRP) test 1 month after PCI. * Discontinue colchicine if the hs-CRP level is less than 2 mg/L, or continue colchicine if it is not. * Visit the clinic for check-ups at 1, 3, 6, 9, and 12 months after PCI.
Interventions
Participants will take low-dose colchicine (0.6 mg once daily) in addition to ticagrelor maintenance therapy (90 mg twice daily), and discontinue aspirin the day after PCI. They will have an hs-CRP test 1 month after PCI. If the hs-CRP level is below 2 mg/L, colchicine will be discontinued 1 month after PCI. If it is 2 mg/L or higher, colchicine will be continued for 12 months after PCI.
Sponsors
CHA University
Biotronik SE & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Participants with positive troponin acute coronary syndrome who have undergone implantation of ultrathin bioresorbable polymer sirolimus-eluting stents (Orsiro; Biotronik AG). * Participants who have provided written informed consent.
Exclusion criteria
* Under 19 years of age. * Stent treatment failure lesions (stent restenosis or thrombosis). * Cardiac arrest or cardiogenic shock. * Currently taking or requiring strong CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir/ritonavir) or P-glycoprotein inhibitors (cyclosporine, ranolazine). * Presence of any of the following concomitant conditions: myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia, severe gastrointestinal diseases, or genetic disorders such as galactose intolerance. * Hypersensitivity to colchicine treatment. * Currently taking colchicine for another condition. * Requiring anticoagulant therapy. * Liver disease classified as Child-Pugh class B or C. * Renal disease with creatinine clearance \<30 mL/min. * Pregnant, breastfeeding, or women of childbearing age. * Currently has a malignancy or has a history of malignancy within the past 5 years. * Life expectancy of less than 5 years. * Contraindication for ticagrelor use (history of intracranial hemorrhage, active pathological bleeding, or liver disease classified as Child-Pugh class B or C). * Patients receiving regular administration of systemic steroids, immunosuppressants, or biological agents (e.g., TNF-alpha inhibitors) * Patients with active infectious diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome: Stent thrombosis | 12 months post-intervention | Definite, probable, or possible stent thrombosis according to the Academic Research Consortium |
| Efficacy Outcome: Net adverse clinical event | 12 months post-intervention | The composite of cardiovascular death, nonfatal spontaneous (nonprocedural) myocardial infarction, nonfatal ischemic stroke, unplanned hospitalization leading to urgent revascularization, and major bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nonfatal spontaneous (nonprocedural) myocardial infarction | 12 months post-intervention | Myocardial infarction is defined as symptoms, electrocardiographic changes, or abnormal imaging findings, combined with a creatine kinase MB fraction above the upper normal limits or a troponin T or troponin I level greater than the 99th percentile of the upper normal limit. Myocardial infarction that are not associated with a revascularization procedure will be classified as nonfatal spontaneous myocardial infarction. |
| Unplanned hospitalization leading to urgent revascularization | 12 months post-intervention | This event will be present only if the participant is hospitalized unexpectedly because of persisting or increasing complaints of chest pain (with or without ST-T changes, with or without elevated biomarkers) and a revascularization is performed within the same hospitalization. It should be clearly distinguished from the revascularization procedure which is performed on non-urgent basis. |
| Major bleeding | 12 months post-intervention | Bleeding Academic Research Consortium type 3 or 5 |
| High residual inflammation | 1 month, 6 months, and 12 months post-intervention | Participant with hs-CRP of ≥2 mg/L |
| High residual platelet reactivity | 1 month and 12 months post-intervention | Participant with P2Y12 reaction units of \>208 |
| Low residual platelet reactivity | 1 month and 12 months post-intervention | Participant with P2Y12 reaction units of \<85 |
| Thrombogenicity | 1 month and 12 months post-intervention | This will be measured using R, K, Angle, A10, MA, and Ly30 through thromboelastography. |
| Nonfatal ischemic stroke | 12 months post-intervention | Cerebrovascular event resulting in a neurologic deficit within 24 hours or the presence of acute infarction as demonstrated by imaging studies will be classified as nonfatal ischemic stroke. |
| Adverse drug reaction to colchicine | 1 month, 3 months, 6 months, 9 months, and 12 months | Response to a colchicine which is noxious and unintended and which occurs during the administration period. |
| Cardiovascular death | 12 months post-intervention | The composite of cardiac and vascular death. Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. Death caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases will be classified as vascular death. |
Countries
South Korea
Contacts
CONTACTHwa-In Kim
PRINCIPAL_INVESTIGATORSeung-Yul Lee, MD
CHA Bundang Medical Center
Outcome results
None listed