Back to resultsISAR-DAPT (A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial)
Primary Purpose
Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Coroflex ISAR
3 months DAPT
6 months DAPT
Sponsored by
About this trial
This is an interventional treatment trial for Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease focused on measuring Stent, Polymer-free, Antiplatelet therapy, Clopidogrel, DES, DAPT
Eligibility Criteria
Inclusion Criteria:
- Patients aged 19 or older
- Patients who have submitted a written consent to participate in the clinical trial
- De novo lesion
- Patients scheduled for elective intervention to treat ischemic cardiovascular disease
Exclusion Criteria:
- Patients with any contraindications or hypersensitivity related to antiplatelet therapy
- Patients with Acute Myocardial Infarction (ST elevation myocardial infarction, Non ST elevation myocardial infarction)
- Patients who are anticipated to receive treatment or surgery that may require desisting the administration of antiplatelet therapy for 2 weeks or longer during the period of the clinical trial
- Chronic total occlusion (CTO) lesions, in-stent restenosis (ISR)
- Patients experiencing cardiogenic shock
- Women who are breastfeeding, pregnant, or desiring pregnancy
- Patients with findings of hemorrhage
- Patients with a life expectancy of less than 1 year
- Patients who have received a drug-eluting stent (DES) procedure within the past 6 months
- Any other patients judged by the investigator to be unsuitable for the trial
Sites / Locations
- Ajou University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Coroflex ISAR 3 months DAPT
Coroflex ISAR 6 months DAPT
Arm Description
Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 3 months
Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 6 months
Outcomes
Primary Outcome Measures
MACE
Major Adverse Cardiac Events (MACE) (cardiac death, recurrent myocardial infarction, target lesion revascularization) at 12 months from the time of the procedure
Secondary Outcome Measures
MACE
Any death, cardiac death, MI, TLR, TVR
Any death, cardiac death, MI, Stroke, TLR, TVR
Full Information
NCT ID
NCT02609698
First Posted
November 18, 2015
Last Updated
November 18, 2015
Sponsor
Ajou University School of Medicine
Collaborators
B. Braun Korea Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02609698
Brief Title
ISAR-DAPT (A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial)
Official Title
A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
Collaborators
B. Braun Korea Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
This clinical trial studies patients treated with the Coroflex ISAR Stent for coronary artery disease in order for the objective of verifying the non-inferiority of results that among patients who were administered DAPT for 3 months compared to patients who were administered DAPT for 6 months, in terms of the efficacy and safety of DAPT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease
Keywords
Stent, Polymer-free, Antiplatelet therapy, Clopidogrel, DES, DAPT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
906 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Coroflex ISAR 3 months DAPT
Arm Type
Experimental
Arm Description
Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 3 months
Arm Title
Coroflex ISAR 6 months DAPT
Arm Type
Active Comparator
Arm Description
Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 6 months
Intervention Type
Device
Intervention Name(s)
Coroflex ISAR
Intervention Description
This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.
Intervention Type
Drug
Intervention Name(s)
3 months DAPT
Other Intervention Name(s)
Aspirin + clopidogrel for 3-months schedule after the coronary stenting
Intervention Type
Drug
Intervention Name(s)
6 months DAPT
Other Intervention Name(s)
Aspirin + clopidogrel for 6-months schedule after the coronary stenting
Primary Outcome Measure Information:
Title
MACE
Description
Major Adverse Cardiac Events (MACE) (cardiac death, recurrent myocardial infarction, target lesion revascularization) at 12 months from the time of the procedure
Time Frame
12 months from the time of the stenting
Secondary Outcome Measure Information:
Title
MACE
Time Frame
6 months from the time of the stenting
Title
Any death, cardiac death, MI, TLR, TVR
Time Frame
6 months from the time of the stenting
Title
Any death, cardiac death, MI, Stroke, TLR, TVR
Time Frame
12 months from the time of the stenting
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 19 or older
Patients who have submitted a written consent to participate in the clinical trial
De novo lesion
Patients scheduled for elective intervention to treat ischemic cardiovascular disease
Exclusion Criteria:
Patients with any contraindications or hypersensitivity related to antiplatelet therapy
Patients with Acute Myocardial Infarction (ST elevation myocardial infarction, Non ST elevation myocardial infarction)
Patients who are anticipated to receive treatment or surgery that may require desisting the administration of antiplatelet therapy for 2 weeks or longer during the period of the clinical trial
Chronic total occlusion (CTO) lesions, in-stent restenosis (ISR)
Patients experiencing cardiogenic shock
Women who are breastfeeding, pregnant, or desiring pregnancy
Patients with findings of hemorrhage
Patients with a life expectancy of less than 1 year
Patients who have received a drug-eluting stent (DES) procedure within the past 6 months
Any other patients judged by the investigator to be unsuitable for the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myeong-Ho Yoon, Ph.D, MD
Phone
+82-31-219-4329
Email
yoonmh65@hanmail.net,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myeong-Ho Yoon, Ph.D, MD
Organizational Affiliation
Cardiovascular Center, Ajou University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Hospital
City
Yeongtong-gu
State/Province
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myeong-Ho Yoon, Ph.D, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
35863061
Citation
Jin U, Seo KW, Yang HM, Lim HS, Choi BJ, Choi SY, Shin JH, Tahk SJ, Yoo SY, Rha SW, Chung WY, Kim CH, Won KB, Pyun WB, Jang JS, Lee SY, Hong YJ, Kim MH, Hong SJ, Choi YS, Kim HY, Choi RK, Kang WC, Cho EJ, Yoon MH. Efficacy and Safety of 3 Versus 6 Months of Dual-Antiplatelet Therapy in Patients Implanted With a Coroflex ISAR Stents: A Prospective, Multicenter, Randomized Clinical Trial. J Invasive Cardiol. 2022 Sep;34(9):E653-E659. Epub 2022 Jul 22.
Results Reference
derived
Learn more about this trial
ISAR-DAPT (A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial)
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