Mono Antiplatelet and Colchicine Therapy

Acute Coronary Syndrome Clinical Trial

— MACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949516
• Other study ID #: WKUH 2021-06-004
• Status: Completed
• Phase: Phase 4
• Start date: June 15, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2022
• Source: Wonkwang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Drug-Eluting Stents
• Syndrome

Intervention

Drug:
• Aspirin
Aspirin is discontinued the day after drug-eluting stent implantation
• Colchicine
Colchicine is started the day after drug-eluting stent implantation

Locations

Country	Name	City	State
Korea, Republic of	Wonkwang University Hospital	Iksan

Sponsors (1)

Lead Sponsor	Collaborator
Wonkwang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Clinical outcomes - All-cause mortality	All-cause mortality	Assessed at hospital stay and 30/90 days after stent implantation
Secondary	Clinical outcomes - Cardiac and non-cardiac mortality	Cardiac and non-cardiac mortality	Assessed at hospital stay and 30/90 days after stent implantation
Secondary	Clinical outcomes - All myocardial infarction	All myocardial infarction	Assessed at hospital stay and 30/90 days after stent implantation
Secondary	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
Secondary	Clinical outcomes - All revascularization	All revascularization	Assessed at hospital stay and 30/90 days after stent implantation
Secondary	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
Secondary	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
Secondary	Laboratory outcomes - P2Y12 reaction unit	P2Y12 reaction unit using VerifyNow P2Y12 rapid analyzer	Assessed at hospital stay
Secondary	Laboratory outcomes - Percent platelet inhibition	Percent platelet inhibition using VerifyNow P2Y12 rapid analyzer	Assessed at hospital stay
Secondary	Laboratory outcomes - C-reactive protein	C-reactive protein	Assessed at hospital stay and 30 days after stent implantation