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

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 490

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

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).

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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