Wonkwang University Hospital
Iksan, 54538, South Korea
NCT Number: NCT04949516
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.
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Notify Me19 year–90 year
All sexes
Interventional
Phase 4
Iksan, 54538, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Aspirin is discontinued the day after drug-eluting stent implantation
Other names: Aspirin stop
Colchicine is started the day after drug-eluting stent implantation
Other names: Colchicine start
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Definite, probable, and possible stent thrombosis (Academic Research Consortium)
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Composite time-to-first event rate of cardiac death, target vessel-myocardial infarction (TV-MI), or ischemia driven-target vessel revascularization (ID-TVR)
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Composite time-to-first event rate of cardiac death, TV-MI, or ischemia driven-target lesion revascularization (ID-TLR)
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
All-cause mortality
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Cardiac and non-cardiac mortality
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
All myocardial infarction
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
TV-MI and non-TV-MI
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
All revascularization
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
ID-TVR, ID-TLR and ID-non-TLR TVR
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Type 1, type 2, type 3, type 4, and type 5 bleeding (Bleeding Academic Research Consortium)
Time frame: Assessed at hospital stay
P2Y12 reaction unit using VerifyNow P2Y12 rapid analyzer
Time frame: Assessed at hospital stay
Percent platelet inhibition using VerifyNow P2Y12 rapid analyzer
Time frame: Assessed at hospital stay and 30 days after stent implantation
C-reactive protein
Wonkwang University Hospital
Other
Aspirin-free Therapy After Successful Percutaneous Coronary Intervention for Acute Coronary Syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) Pilot Study
Acronym: MACT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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