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
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 906
- Locations
- 1
- Primary Endpoint
- MACE
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Coroflex ISAR (Device)
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
Intervention: 3 months DAPT (Drug)
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
Intervention: Coroflex ISAR (Device)
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
Intervention: 6 months DAPT (Drug)
Outcomes
Primary Outcomes
MACE
Time Frame: 12 months from the time of the stenting
Major Adverse Cardiac Events (MACE) (cardiac death, recurrent myocardial infarction, target lesion revascularization) at 12 months from the time of the procedure
Secondary Outcomes
- MACE(6 months from the time of the stenting)
- Any death, cardiac death, MI, Stroke, TLR, TVR(12 months from the time of the stenting)
- Any death, cardiac death, MI, TLR, TVR(6 months from the time of the stenting)
Investigators
Myeong-Ho Yoon
Professor, Dept of Cardiology
Ajou University School of Medicine