Mono Antiplatelet and Colchicine Therapy (MACT)

Wonkwang University Hospital

Status and phase: Completed; Phase 4

Conditions: Drug-Eluting Stents; Acute Coronary Syndrome

Treatments: Drug: Aspirin; Drug: Colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT04949516

WKUH 2021-06-004

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of aspirin-free, P2Y12 inhibitor single antiplatelet and colchicine treatment in patients with acute coronary syndrome treated with drug-eluting stents.

Full description

After successful drug-eluting stent implantation for acute coronary syndrome, screening for study subject enrollment is performed. For those who submitted written informed consent, aspirin is stopped the day after the intervention, and colchicine 0.6mg once daily is started. The P2Y12 inhibitor, prasugrel or ticagrelor, for single antiplatelet therapy remains. For the duration of hospital stay, platelet reactivity using VerifyNow test and C-reactive protein are measured. Aspirin may be restarted at the discretion of the investigator based on results of the platelet function test. C-reactive protein is remeasured 30 days after the intervention. Clinical follow-up is performed 30 days and 90 days after the intervention.

Enrollment: 200 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successful PCI with drug-eluting stent for NSTE-ACS or STEMI
• Provision of written informed consent

Exclusion criteria

• Cardiac arrest or cardiogenic shock
• Age <19 or >90 years old
• Severe liver impairment
• Severe renal impairment (eGFR <30 mL/min/1.73 m2)
• Atrial fibrillation requiring anticoagulation therapy
• Intolerance of prasugrel, ticagrelor, or colchicine
• History of intracranial hemorrhage
• Active bleeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Mono Antiplatelet and Colchicine Therapy

Experimental group

Description:

Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment

Treatment:

Drug: Colchicine

Drug: Aspirin