Actively Recruiting

Phase 4
Age: 20Years - 90Years
All Genders
NCT06543082

MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study

Led by CHA University · Updated on 2026-02-18

490

Participants Needed

9

Research Sites

225 weeks

Total Duration

On this page

Sponsors

C

CHA University

Lead Sponsor

B

Biotronik SE & Co. KG

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study

Who Can Participate

Age: 20Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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 or P-glycoprotein inhibitors.
  • Presence of 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 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.
  • Patients with active infectious diseases.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 9 locations

1

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea, 13496

Actively Recruiting

2

Keimyung University Dongsan Hospital

Daegu, South Korea

Actively Recruiting

3

Wonkwang University Hospital

Iksan, South Korea

Actively Recruiting

4

Myongji Hospital

Ilsan, South Korea

Actively Recruiting

5

National Health Insurance Service Ilsan Hospital

Ilsan, South Korea

Actively Recruiting

6

Seoul National University Bundang Hospital

Seongnam, South Korea

Actively Recruiting

7

Ewha Womans University Seoul Hospital

Seoul, South Korea

Actively Recruiting

8

Gangnam Severance Hospital

Seoul, South Korea

Actively Recruiting

9

Wonju Severance Christian Hospital

Wŏnju, South Korea

Actively Recruiting

Loading map...

Research Team

H

Hwa-In Kim

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study | DecenTrialz