Coronary Artery Disease
Conditions
Keywords
Coronary artery disease, Dual antiplatelet platelet therapy, Drug eluting stent
Brief summary
The purpose of this study is to compare short-term (6-month Dual Anti Platelet Therapy(DAPT) followed by clopidogrel monotherapy) vs. standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy) on clinically relevant bleeding complications (Bleeding Academic Research Consortium(BARC) type 2, 3, or 5)31 in patients after zotarolimus-eluting stent implantation.
Interventions
DRUGClopidogrel
6-month DAPT followed by clopidogrel monotherapy
standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy)
Sponsors
CardioVascular Research Foundation, Korea
Medtronic
Chong Kun Dang Pharmaceutical Corp.
CHEOL WHAN LEE, M.D., Ph.D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women at least 19 years of age * Patients with stable coronary artery disease who were successfully treated with zotarolimus-eluting stents * Patients without major bleeding or MACE (myocardial infarction, stent thrombosis, stoke, repeat revascularization) within 6 months after zotarolimus-eluting stent placement * The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion criteria
* Persistent thrombocytopenia (platelet count \<100,000/µl) * A known intolerance to a study drug (aspirin, clopidogrel) * Patients requiring long-term oral anticoagulants or cilostazol * Patients presented with acute myocardial infarction (STEMI or NSTEMI) at the time of index procedure * Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within 18 months after procedure * Bare-metal stent implantation at the time of index procedure * Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible). * A diagnosis of cancer in the past 2 years or current treatment for the active cancer. * Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study. * Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal). * History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s). * Unwillingness or inability to comply with the procedures described in this protocol. * Patients pregnant or breast-feeding or child-bearing potential.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with clinically relevant bleeding | 18 months | clinically relevant bleeding (Bleeding Academic Research Consortium Definition: type 2, 3, or 5) at 18 months after randomization (6-24 months after the procedure) |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with myocardial infarction | 18 months |
| Number of participants with stroke | 18 months |
| Number of participants with stent thrombosis | 18 months |
| Number of participants with repeat revascularization | 18 months |
| Number of participants with BARC(Bleeding Academic Research Consortium Definition) type 3 or 5 | 18 months |
| Number of participants with death from cardiovascular cause | 18 months |
| Number of participants with a composite of death from cardiovascular causes, myocardial infarction, stroke, stent thrombosis | 18 months |
| Number of participants with a composite of death from vascular causes, myocardial infarction, stroke, stent thrombosis, BARC type 3 or 5 | 18 months |
| Number of participants with gastrointestinal side effects (gastric or duodenal active ulcer, perforation, gastrointestinal bleeding) | 18 months |
| Number of participants with a composite of BARC(Bleeding Academic Research Consortium Definition) 2, 3, 5 or gastrointestinal side effects. | 18 months |
| Number of participants with a composite of death from vascular causes or myocardial infarction | 18 months |
Countries
South Korea
Outcome results
None listed