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)
NCT ID: NCT02609698
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
906 participants
INTERVENTIONAL
2015-08-31
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Coroflex ISAR 3 months DAPT
Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 3 months
Coroflex ISAR
This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.
3 months DAPT
Coroflex ISAR 6 months DAPT
Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 6 months
Coroflex ISAR
This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.
6 months DAPT
Interventions
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Coroflex ISAR
This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.
3 months DAPT
6 months DAPT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who have submitted a written consent to participate in the clinical trial
3. De novo lesion
4. Patients scheduled for elective intervention to treat ischemic cardiovascular disease
Exclusion Criteria
2. Patients with Acute Myocardial Infarction (ST elevation myocardial infarction, Non ST elevation myocardial infarction)
3. 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
4. Chronic total occlusion (CTO) lesions, in-stent restenosis (ISR)
5. Patients experiencing cardiogenic shock
6. Women who are breastfeeding, pregnant, or desiring pregnancy
7. Patients with findings of hemorrhage
8. Patients with a life expectancy of less than 1 year
9. Patients who have received a drug-eluting stent (DES) procedure within the past 6 months
10. Any other patients judged by the investigator to be unsuitable for the trial
ALL
No
Sponsors
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B. Braun Korea Co., Ltd.
INDUSTRY
Ajou University School of Medicine
OTHER
Responsible Party
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Myeong-Ho Yoon
Professor, Dept of Cardiology
Principal Investigators
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Myeong-Ho Yoon, Ph.D, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Center, Ajou University Hospital
Locations
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Ajou University Hospital
Yeongtong-gu, Suwon, South Korea
Countries
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Central Contacts
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Facility Contacts
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Myeong-Ho Yoon, Ph.D, MD
Role: primary
References
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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. doi: 10.25270/jic/21.00330. Epub 2022 Jul 22.
Other Identifiers
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AJOU-CV-0001
Identifier Type: -
Identifier Source: org_study_id