Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation (STAMP-DES)

CHEOL WHAN LEE, M.D., Ph.D

Status and phase

Terminated

Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: Clopidogrel

Drug: Aspirin plus clopidogrel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02494284

AMCCV2014-09

Details and patient eligibility

About

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.

Enrollment

364 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.