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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clopidogrel
Aspirin plus clopidogrel
Sponsored by
CHEOL WHAN LEE, M.D., Ph.D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Dual antiplatelet platelet therapy, Drug eluting stent

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cheju Halla General Hospital
  • Keimyung University Dongsan Medical Center
  • Eulji University Hospital
  • Gangneung Asan Hospital
  • Inje University Ilsan Paik Hospital
  • Asan Medical Center
  • Kangbuk Samsung Medical Center
  • Kyunghee University Medical Center
  • SMA-SNU Boramae Medical Center
  • The Catholic University of Korea St. Paul's Hospital
  • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short term dual therapy

Long term dual therapy

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of participants with death from cardiovascular cause
Number of participants with myocardial infarction
Number of participants with stroke
Number of participants with stent thrombosis
Number of participants with repeat revascularization
Number of participants with BARC(Bleeding Academic Research Consortium Definition) type 3 or 5
Number of participants with a composite of death from vascular causes or myocardial infarction
Number of participants with a composite of death from cardiovascular causes, myocardial infarction, stroke, stent thrombosis
Number of participants with a composite of death from vascular causes, myocardial infarction, stroke, stent thrombosis, BARC type 3 or 5
Number of participants with gastrointestinal side effects (gastric or duodenal active ulcer, perforation, gastrointestinal bleeding)
Number of participants with a composite of BARC(Bleeding Academic Research Consortium Definition) 2, 3, 5 or gastrointestinal side effects.

Full Information

First Posted
July 5, 2015
Last Updated
February 20, 2017
Sponsor
CHEOL WHAN LEE, M.D., Ph.D
Collaborators
CardioVascular Research Foundation, Korea, Medtronic, Chong Kun Dang Pharmaceutical Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT02494284
Brief Title
Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation
Acronym
STAMP-DES
Official Title
Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation : STAMP-DES Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
December 22, 2015 (Actual)
Primary Completion Date
February 13, 2017 (Actual)
Study Completion Date
February 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CHEOL WHAN LEE, M.D., Ph.D
Collaborators
CardioVascular Research Foundation, Korea, Medtronic, Chong Kun Dang Pharmaceutical Corp.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Dual antiplatelet platelet therapy, Drug eluting stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
364 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short term dual therapy
Arm Type
Experimental
Arm Title
Long term dual therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
6-month DAPT followed by clopidogrel monotherapy
Intervention Type
Drug
Intervention Name(s)
Aspirin plus clopidogrel
Intervention Description
standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy)
Primary Outcome Measure Information:
Title
Number of participants with clinically relevant bleeding
Description
clinically relevant bleeding (Bleeding Academic Research Consortium Definition: type 2, 3, or 5) at 18 months after randomization (6-24 months after the procedure)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Number of participants with death from cardiovascular cause
Time Frame
18 months
Title
Number of participants with myocardial infarction
Time Frame
18 months
Title
Number of participants with stroke
Time Frame
18 months
Title
Number of participants with stent thrombosis
Time Frame
18 months
Title
Number of participants with repeat revascularization
Time Frame
18 months
Title
Number of participants with BARC(Bleeding Academic Research Consortium Definition) type 3 or 5
Time Frame
18 months
Title
Number of participants with a composite of death from vascular causes or myocardial infarction
Time Frame
18 months
Title
Number of participants with a composite of death from cardiovascular causes, myocardial infarction, stroke, stent thrombosis
Time Frame
18 months
Title
Number of participants with a composite of death from vascular causes, myocardial infarction, stroke, stent thrombosis, BARC type 3 or 5
Time Frame
18 months
Title
Number of participants with gastrointestinal side effects (gastric or duodenal active ulcer, perforation, gastrointestinal bleeding)
Time Frame
18 months
Title
Number of participants with a composite of BARC(Bleeding Academic Research Consortium Definition) 2, 3, 5 or gastrointestinal side effects.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jung Park, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheol-Whan Lee, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cheju Halla General Hospital
City
Cheju
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Eulji University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Gangneung Asan Hospital
City
Gangneung
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Kyunghee University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
SMA-SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St. Paul's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Yeouido St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

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

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