Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation

• Status: Terminated
• Trial end date: 2017-02-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CHEOL WHAN LEE, M.D., Ph.D
• Collaborators: CardioVascular Research Foundation, Korea; Chong Kun Dang Pharmaceutical Corp.; Medtronic
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

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.