Clinical trial NCT02609698: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease
Keywords: Stent
Polymer-free
Antiplatelet therapy
Clopidogrel
DES
DAPT
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: B. Braun Korea Co., Ltd.
First posted: 2015-11-20
Enrollment: 906
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 19 or older
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:

1. Patients with any contraindications or hypersensitivity related to antiplatelet therapy
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

Primary outcomes:
measure: MACE
timeFrame: 12 months from the time of the stenting
Secondary outcomes:
measure: MACE
timeFrame: 6 months from the time of the stenting
measure: Any death, cardiac death, MI, TLR, TVR
timeFrame: 6 months from the time of the stenting
measure: Any death, cardiac death, MI, Stroke, TLR, TVR
timeFrame: 12 months from the time of the stenting
Other outcomes:
Locations:
city: Yeongtong-gu
country: Korea, Republic of
facility: Ajou University Hospital
state: Suwon
Study officials:
affiliation: Cardiovascular Center, Ajou University Hospital
name: Myeong-Ho Yoon, Ph.D, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.25270/jic/21.00330. Epub 2022 Jul 22.