The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent (DATE)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aspirin, Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Angioplasty, Transluminal, Percutaneous Coronary, Stent thrombosis, Zotarolimus-eluting stent
Eligibility Criteria
Inclusion Criteria:
- Patients with clinically significant de novo coronary artery disease
- Stenting only with Endeavor® stents
- The sum of stent length is less than 60 mm for one lesion. The sum of stent length in multiple lesions does not matter.
Exclusion Criteria:
- Cardiogenic shock
- ST-elevation myocardial infarction within 48 hours of symptom onset
- Prior implantation of drug-eluting stents
- Left ventricular dysfunction (echocardiographic left ventricular ejection fraction < 25%)
- Stenting both branch of bifurcation lesion
- Left main trunk lesion
- Graft vessels
- Patients who have to receive clopidogrel due to other conditions
- Patients who have to receive warfarin, cilostazol or other antiplatelet therapy
- Patient with chronic renal failure (S-Cr > 2.0 mg/dl)
- Hypersensitivity to clopidogrel or aspirin
- Expectant survival less than 1 year
- Women who plan to become pregnant
- Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard
Secondary Outcome Measures
Full Information
NCT ID
NCT00418860
First Posted
January 3, 2007
Last Updated
August 10, 2011
Sponsor
Samsung Medical Center
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00418860
Brief Title
The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent
Acronym
DATE
Official Title
The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent in the Patients With Coronary Artery Disease (DATE Registry)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study to determine whether the dual antiplatelet therapy (aspirin and clopidogrel) for 3 months after coronary implantation of zotarolimus-eluting stent is safe in terms of death, myocardial infarction, or stent thrombosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Angioplasty, Transluminal, Percutaneous Coronary, Stent thrombosis, Zotarolimus-eluting stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aspirin, Clopidogrel
Other Intervention Name(s)
plavix
Intervention Description
Aspirin 100mg qd plus clopidogrel 75mg qd for 3 month after index procedure
Primary Outcome Measure Information:
Title
Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with clinically significant de novo coronary artery disease
Stenting only with Endeavor® stents
The sum of stent length is less than 60 mm for one lesion. The sum of stent length in multiple lesions does not matter.
Exclusion Criteria:
Cardiogenic shock
ST-elevation myocardial infarction within 48 hours of symptom onset
Prior implantation of drug-eluting stents
Left ventricular dysfunction (echocardiographic left ventricular ejection fraction < 25%)
Stenting both branch of bifurcation lesion
Left main trunk lesion
Graft vessels
Patients who have to receive clopidogrel due to other conditions
Patients who have to receive warfarin, cilostazol or other antiplatelet therapy
Patient with chronic renal failure (S-Cr > 2.0 mg/dl)
Hypersensitivity to clopidogrel or aspirin
Expectant survival less than 1 year
Women who plan to become pregnant
Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeon-Cheol Gwon, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent
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