Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation
- Conditions
- Coronary Artery Disease
- Interventions
- Registration Number
- NCT02494284
- Lead Sponsor
- CHEOL WHAN LEE, M.D., Ph.D
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 364
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Long term dual therapy Aspirin plus clopidogrel - Short term dual therapy Clopidogrel -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of participants with stent thrombosis 18 months Number of participants with repeat revascularization 18 months Number of participants with death from cardiovascular cause 18 months Number of participants with myocardial infarction 18 months Number of participants with stroke 18 months Number of participants with BARC(Bleeding Academic Research Consortium Definition) type 3 or 5 18 months Number of participants with a composite of death from vascular causes or myocardial infarction 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 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 a composite of BARC(Bleeding Academic Research Consortium Definition) 2, 3, 5 or gastrointestinal side effects. 18 months
Trial Locations
- Locations (12)
Cheju Halla General Hospital
🇰🇷Cheju, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Eulji University Hospital
🇰🇷Daejeon, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Ilsan, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
SMA-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Kyunghee University Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea St. Paul's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of