Mono Antiplatelet and Colchicine Therapy (MACT)

Aspirin-free Therapy After Successful Percutaneous Coronary Intervention for Acute Coronary Syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; Drug-Eluting Stents
• Intervention / Treatment: Drug: Aspirin; Drug: Colchicine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Iksan, Korea, Republic of, 54538
    • Wonkwang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mono Antiplatelet and Colchicine Therapy; Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment	Drug: Aspirin; Aspirin is discontinued the day after drug-eluting stent implantation; Other Names: Aspirin stop; Drug: Colchicine; Colchicine is started the day after drug-eluting stent implantation; Other Names: Colchicine start

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcomes - Definite, probable, and possible stent thrombosis (Academic Research Consortium)	Definite, probable, and possible stent thrombosis (Academic Research Consortium)	Assessed at hospital stay and 30/90 days after stent implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcomes - Target vessel failure	Composite time-to-first event rate of cardiac death, target vessel-myocardial infarction (TV-MI), or ischemia driven-target vessel revascularization (ID-TVR)	Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - Target lesion failure	Composite time-to-first event rate of cardiac death, TV-MI, or ischemia driven-target lesion revascularization (ID-TLR)	Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - All-cause mortality	All-cause mortality	Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - Cardiac and non-cardiac mortality	Cardiac and non-cardiac mortality	Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - All myocardial infarction	All myocardial infarction	Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - TV-MI and non-TV-MI	TV-MI and non-TV-MI	Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - All revascularization	All revascularization	Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - ID-TVR, ID-TLR and ID-non-TLR TVR	ID-TVR, ID-TLR and ID-non-TLR TVR	Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)	Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)	Assessed at hospital stay and 30/90 days after stent implantation
Laboratory outcomes - P2Y12 reaction unit	P2Y12 reaction unit using VerifyNow P2Y12 rapid analyzer	Assessed at hospital stay
Laboratory outcomes - Percent platelet inhibition	Percent platelet inhibition using VerifyNow P2Y12 rapid analyzer	Assessed at hospital stay
Laboratory outcomes - C-reactive protein	C-reactive protein	Assessed at hospital stay and 30 days after stent implantation

Collaborators and Investigators

• Sponsor: Wonkwang University Hospital
• Investigators: Principal Investigator: Seung-Yul Lee, MD, Wonkwang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: December 31, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Platelet Aggregation Inhibitors; Colchicine
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Aspirin; Colchicine
• Other Study ID Numbers: WKUH 2021-06-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No