Study Stopped
Slow enrollment
Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation
STAMP-DES
1 other identifier
interventional
364
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 coronary-artery-disease
Started Dec 2015
Shorter than P25 for phase_4 coronary-artery-disease
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2015
CompletedFirst Posted
Study publicly available on registry
July 10, 2015
CompletedStudy Start
First participant enrolled
December 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2017
CompletedFebruary 23, 2017
February 1, 2017
1.1 years
July 5, 2015
February 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with clinically relevant bleeding
clinically relevant bleeding (Bleeding Academic Research Consortium Definition: type 2, 3, or 5) at 18 months after randomization (6-24 months after the procedure)
18 months
Secondary Outcomes (11)
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 stent thrombosis
18 months
Number of participants with repeat revascularization
18 months
- +6 more secondary outcomes
Study Arms (2)
Short term dual therapy
EXPERIMENTALLong term dual therapy
ACTIVE COMPARATORInterventions
standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHEOL WHAN LEE, M.D., Ph.Dlead
- CardioVascular Research Foundation, Koreacollaborator
- Medtroniccollaborator
- Chong Kun Dang Pharmaceutical Corp.collaborator
Study Sites (12)
Keimyung University Dongsan Medical Center
Daegu, South Korea
Eulji University Hospital
Daejeon, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Inje University Ilsan Paik Hospital
Ilsan, South Korea
Cheju Halla General Hospital
Jeju City, South Korea
Asan Medical Center
Seoul, South Korea
Kangbuk Samsung Medical Center
Seoul, South Korea
Kyunghee University Medical Center
Seoul, South Korea
SMA-SNU Boramae Medical Center
Seoul, South Korea
The Catholic University of Korea St. Paul's Hospital
Seoul, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jung Park, MD
Asan Medical Center
- PRINCIPAL INVESTIGATOR
Cheol-Whan Lee, MD
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D., Ph,D
Study Record Dates
First Submitted
July 5, 2015
First Posted
July 10, 2015
Study Start
December 22, 2015
Primary Completion
February 13, 2017
Study Completion
February 13, 2017
Last Updated
February 23, 2017
Record last verified: 2017-02