Status:
RECRUITING
MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study
Lead Sponsor:
CHA University
Collaborating Sponsors:
Biotronik SE & Co. KG
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
20-90 years
Phase:
PHASE4
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 af...
Eligibility Criteria
Inclusion
- 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
- 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 \<50 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).
Key Trial Info
Start Date :
August 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT06543082
Start Date
August 5 2024
End Date
December 31 2028
Last Update
December 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea, 13496