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Clinical outcomes of colchicine therapy following percutaneous coronary intervention in patient s with acute coronary syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) prospective multicenter observational study

Clinical outcomes of colchicine therapy following percutaneous coronary intervention in patients with acute coronary syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) prospective multicenter observational study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0009444
Enrollment
490
Registered
2024-05-17
Start date
2024-06-25
Completion date
Unknown
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The selection process for enrollment in a study following successful percutaneous coronary intervention (PCI) is conducted. Patients who meet the selection and exclusion criteria are eligible f
if hs-CRP is <2 mg/L, colchicine is discontinued at 1 month after the intervention. If a P2Y12 inhibitor such as clopidogrel or prasugrel was taken before the intervention, clopidogrel or prasugrel i

Sponsors

Bundang CHA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. A patient with positive troponin presenting with acute coronary syndrome who underwent insertion of ultrathin bioresorbable polymer sirolimus-eluting stents (Orsiro; Biotronik AG). 2. A patient who has submitted a written informed consent for the research study.

Exclusion criteria

Exclusion criteria: 1. Patients under the age of 19. 2. Patients experiencing cardiac arrest or cardiogenic shock. 3. Patients currently taking or requiring potent CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir/ritonavir) or P-glycoprotein inhibitors (cyclosporine, ranolazine). 4. Patients with the following concomitant conditions: myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia, severe gastrointestinal disorders, or genetic disorders such as galactose intolerance. 5. Patients with hypersensitivity to colchicine therapy. 6. Patients currently taking colchicine for another condition. 7. Patients requiring anticoagulant therapy. 8. Patients with liver disease of Child-Pugh class B or C. 9. Patients with renal disease and a creatinine clearance <50 mL/min. 10. Women of childbearing potential, breastfeeding, or pregnant women. 11. Patients currently diagnosed with cancer or with a history of malignant tumors within the past 5 years. 12. Patients with a life expectancy of less than 5 years. 13. Contraindication to ticagrelor use (history of intracranial bleeding, active pathological bleeding, liver disease of Child-Pugh class B or C).

Design outcomes

Primary

MeasureTime frame
Efficacy: cardiovascular death, nonfatal spontaneous(nonprocedural) MI, nonfatal ischemic stroke, unplanned hospitalization leading to urgent revascularization, or BARC type3 or 5 bleeding;Safety: stent thrombosis at 12month

Secondary

MeasureTime frame
Components of primary outcomes;Frequency of hs-CRP =2 mg/L;The relationship between colchicine therapy and hs-CRP levels based on clinical diagnosis;Changes in hs-CRP levels following discontinuation of colchicine;PRU(Platelet Reactivity Units), R(Reaction Time), MA(Maximum Amplitude);Adverse reactions of colchicine

Countries

Korea, Republic of

Contacts

Public ContactSeung-Yul Lee

Bundang CHA General Hospital

seungyul79@gmail.com+82-31-780-5858

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026