Clinical trial NCT04949516: Mono Antiplatelet and Colchicine Therapy
Official title: Aspirin-free Therapy After Successful Percutaneous Coronary Intervention for Acute Coronary Syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Drug-Eluting Stents
Keywords: Platelet Aggregation Inhibitors
Colchicine
Lead sponsor: Wonkwang University Hospital
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical outcomes - Definite, probable, and possible stent thrombosis (Academic Research Consortium)
timeFrame: Assessed at hospital stay and 30/90 days after stent implantation
Secondary outcomes:
measure: Clinical outcomes - Target vessel failure
timeFrame: Assessed at hospital stay and 30/90 days after stent implantation
measure: Clinical outcomes - Target lesion failure
timeFrame: Assessed at hospital stay and 30/90 days after stent implantation
measure: Clinical outcomes - All-cause mortality
timeFrame: Assessed at hospital stay and 30/90 days after stent implantation
measure: Clinical outcomes - Cardiac and non-cardiac mortality
timeFrame: Assessed at hospital stay and 30/90 days after stent implantation
measure: Clinical outcomes - All myocardial infarction
timeFrame: Assessed at hospital stay and 30/90 days after stent implantation
measure: Clinical outcomes - TV-MI and non-TV-MI
timeFrame: Assessed at hospital stay and 30/90 days after stent implantation
measure: Clinical outcomes - All revascularization
timeFrame: Assessed at hospital stay and 30/90 days after stent implantation
measure: Clinical outcomes - ID-TVR, ID-TLR and ID-non-TLR TVR
timeFrame: Assessed at hospital stay and 30/90 days after stent implantation
measure: Clinical outcomes - Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)
timeFrame: Assessed at hospital stay and 30/90 days after stent implantation
measure: Laboratory outcomes - P2Y12 reaction unit
timeFrame: Assessed at hospital stay
measure: Laboratory outcomes - Percent platelet inhibition
timeFrame: Assessed at hospital stay
measure: Laboratory outcomes - C-reactive protein
timeFrame: Assessed at hospital stay and 30 days after stent implantation
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
Study officials:
affiliation: Wonkwang University Hospital
name: Seung-Yul Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: