A Phase 4 interventional study of Aspirin and Colchicine in Acute Coronary Syndrome and Drug-Eluting Stents, sponsored by Wonkwang University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by Wonkwang University Hospital · Phase 4, Interventional, and Treatment
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.
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.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 200 is close to the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Wonkwang University Hospital is the lead sponsor of 26 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Aspirin-free, single P2Y12 inhibitor (prasugrel or ticagrelor) and colchicine treatment
Drug: Aspirin · Drug: Colchicine
Aspirin is discontinued the day after drug-eluting stent implantation
Also known as: Aspirin stop
Colchicine is started the day after drug-eluting stent implantation
Also known as: Colchicine start
Clinical outcomes - Definite, probable, and possible stent thrombosis (Academic Research Consortium)
Definite, probable, and possible stent thrombosis (Academic Research Consortium)
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
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)
Time frame: 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)
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - All-cause mortality
All-cause mortality
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - Cardiac and non-cardiac mortality
Cardiac and non-cardiac mortality
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - All myocardial infarction
All myocardial infarction
Time frame: 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
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Clinical outcomes - All revascularization
All revascularization
Time frame: 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
Time frame: 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)
Time frame: Assessed at hospital stay and 30/90 days after stent implantation
Laboratory outcomes - P2Y12 reaction unit
P2Y12 reaction unit using VerifyNow P2Y12 rapid analyzer
Time frame: Assessed at hospital stay
Laboratory outcomes - Percent platelet inhibition
Percent platelet inhibition using VerifyNow P2Y12 rapid analyzer
Time frame: Assessed at hospital stay
Laboratory outcomes - C-reactive protein
C-reactive protein
Time frame: Assessed at hospital stay and 30 days after stent implantation
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wonkwang University Hospital