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
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 906
- 试验地点
- 1
- 主要终点
- MACE
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 6 months DAPT (Drug)
结局指标
主要结局
MACE
时间窗: 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
次要结局
- 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)
研究者
Myeong-Ho Yoon
Professor, Dept of Cardiology
Ajou University School of Medicine