A Multicenter, Randomized, Outcomes Assessor Blind, Parallel Controlled Trial to Evaluate the Effect of Oral Isosorbide Mononitrate Plus Amlodipine Antispasm Therapy on Outcomes of Radial Artery Grafts After Coronary Artery Bypass Grafting
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The rate of RA graft failure at Week 24
研究概览
简要总结
The goal of this clinical trial is to to evaluate the effect of oral isosorbide mononitrate plus amlodipine antispasm therapy on outcomes of radial artery grafts in patients underwent primary isolated CABG.
The main question it aims to answer is:
Whether the oral isosorbide mononitrate plus amlodipine antispasm therapy could reduce the failure outcome of radial artery grafts after CABG .
Researchers will compare isosorbide mononitrate plus amlodipine to none to see if isosorbide mononitrate plus amlodipine works.
Participants will
- Take oral isosorbide mononitrate (20-40mg daily) plus amlodipine (2.5-5mg daily) therapy for 24 weeks after CABG.
- Clinical follow-up at Week 1, 4, 12, and 24 after CABG.
- Protocol-driven CCTA at Week 24 after CABG.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years old，
- •Signed informed consent，
- •Within 3 days after primary isolated CABG using RA graft
排除标准
- •Allergy to isosorbide mononitrate or amlodipine.
- •Hypotension (systolic BP <90 mmHg or diastolic BP <60 mmHg)
- •Acute myocardial infarction or cardiogenic shock
- •Contraindications for CCTA examination (eg., iodine allergy)
研究组 & 干预措施
Isosorbide Mononitrate + Amlodipine
Oral isosorbide mononitrate 40mg (if unable to tolerate, use 20mg) once daily + amlodipine 5mg (if unable to tolerate, use 2.5mg) once daily for 24 weeks after CABG
干预措施: Oral isosorbide mononitrate 4+ amlodipine (Drug)
结局指标
主要结局
The rate of RA graft failure at Week 24
时间窗: at Week 24
A protocol-driven CCTA will be used to evaluate the RA graft outcome at Week 24 after CABG. Fitzgibbon Grade B/S/O is definned as Graft Failure.
次要结局
- The time to first Major Adverse Cardiovascular Event (MACE)(within 24 weeks)
- The proportion of participants with at least once symptomatic hypotension(within 24 weeks)
研究者
Qiang Zhao,MD
Professor and Director of Cardiovascular Surgery
Ruijin Hospital