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

CHEOL WHAN LEE, M.D., Ph.D12 sites in 1 country364 target enrollmentDecember 22, 2015

ConditionsCoronary Artery Disease

InterventionsClopidogrel Aspirin plus clopidogrel

DrugsClopidogrel Aspirin plus clopidogrel

Overview

Phase: Phase 4
Intervention: Clopidogrel
Conditions: Coronary Artery Disease
Sponsor: CHEOL WHAN LEE, M.D., Ph.D
Enrollment: 364
Locations: 12
Primary Endpoint: Number of participants with clinically relevant bleeding
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 22, 2015

End Date

February 13, 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor Investigator

Principal Investigator

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

M.D., Ph,D

Asan Medical Center

Eligibility 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).

Arms & Interventions

Short term dual therapy

Intervention: Clopidogrel

Long term dual therapy

Intervention: Aspirin plus clopidogrel

Outcomes

Primary Outcomes

Number of participants with clinically relevant bleeding

Time Frame: 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 Outcomes

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)