Coronary Artery Disease
Conditions
Keywords
Drug-eluting stents, aspirin, P2Y12 antagonist monotherapy
Brief summary
To compare the efficacy and safety of clopidogrel monotherapy versus aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with DES.
Detailed description
This trial is a prospective, randomized, multi-center, open label, noninferiority trial. Patients undergoing PCI with DES will be eligible. After successful PCI with DES, all eligible patients will be randomized either to clopidogrel monotherapy or to aspirin plus P2Y12 antagonist following 3-month of DAPT.
Interventions
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be at least 20 years of age. * Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. * Patients undergoing successful PCI
Exclusion criteria
* Hemodynamic instability or cardiogenic shock * Active bleeding * Known hypersensitivity or contraindication to study medications * Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study * Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment). * DES implantation within 12 months before index procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A composite of death, myocardial infarction, or cerebrovascular events | 1 year | 12 months after the index procedure |
Secondary
| Measure | Time frame |
|---|---|
| cardiac death | 1 years |
| Myocardial infarction (MI) | 1 years |
| Cerebrovascular accident (CVA) | 1 years |
| Target lesion revascularization (TLR) | 1 years |
| Target vessel revascularization (TVR) | 1 years |
| All cause Death | 1 years |
| Stent thrombosis: definite or probable stent thrombosis by ARC definition | 1 years |
| BARC bleeding ≥2 | 1 years |
| BARC bleeding ≥3 | 1 years |
| Major adverse cardiocerebral event (MACCE): death, MI, CVA, or any revascularization | 1 years |
| Any revascularization | 1 years |
Countries
South Korea
Outcome results
None listed