Clinical trial NCT02494284: Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation
Official title: Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation : STAMP-DES Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Dual antiplatelet platelet therapy
Drug eluting stent
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
name: Medtronic
name: Chong Kun Dang Pharmaceutical Corp.
First posted: 2015-07-10
Enrollment: 364
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).
* 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.

Primary outcomes:
measure: Number of participants with clinically relevant bleeding
timeFrame: 18 months
Secondary outcomes:
measure: Number of participants with death from cardiovascular cause
timeFrame: 18 months
measure: Number of participants with myocardial infarction
timeFrame: 18 months
measure: Number of participants with stroke
timeFrame: 18 months
measure: Number of participants with stent thrombosis
timeFrame: 18 months
measure: Number of participants with repeat revascularization
timeFrame: 18 months
measure: Number of participants with BARC(Bleeding Academic Research Consortium Definition) type 3 or 5
timeFrame: 18 months
measure: Number of participants with a composite of death from vascular causes or myocardial infarction
timeFrame: 18 months
measure: Number of participants with a composite of death from cardiovascular causes, myocardial infarction, stroke, stent thrombosis
timeFrame: 18 months
measure: Number of participants with a composite of death from vascular causes, myocardial infarction, stroke, stent thrombosis, BARC type 3 or 5
timeFrame: 18 months
measure: Number of participants with gastrointestinal side effects (gastric or duodenal active ulcer, perforation, gastrointestinal bleeding)
timeFrame: 18 months
measure: Number of participants with a composite of BARC(Bleeding Academic Research Consortium Definition) 2, 3, 5 or gastrointestinal side effects.
timeFrame: 18 months
Other outcomes:
Locations:
city: Cheju
country: Korea, Republic of
facility: Cheju Halla General Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
city: Seoul
country: Korea, Republic of
facility: SMA-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea St. Paul's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Cheol-Whan Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: