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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04949516
Other study ID # WKUH 2021-06-004
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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