MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study (MACT II)

CHA University

Status and phase

Enrolling

Phase 4

Conditions

Acute Coronary Syndrome

Treatments

Drug: Colchicine 0.6 mg

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06543082

CHAMC IRB 2024-01-057-009

Details and patient eligibility

About

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.

Enrollment

490 estimated patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

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 <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).