Comparison of VERapamil vs. Heparin Therapy on Procedural sUccess During Transradial Coronary Procedures (VERMUT Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- number of participants with radial artery-related complications
研究概览
简要总结
Transradial approach (TRA) for cardiac catheterization and percutaneous coronary interventions (PCI) is increasingly being used worldwide. At the present is unknown the cocktail of agents necessary to minimize local access site complications. The investigators planned a prospective randomized clinical trial to test the superiority of verapamil vs. heparin in the reduction of access site related complications.
详细描述
Transradial approach (TRA) for cardiac catheterization and percutaneous coronary interventions (PCI) is increasingly being used worldwide in both elective and emergency procedures because it reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality, when compared to transfemoral approach. However, radial artery occlusion (RAO) after the procedure (the incidence of which varies from 1% to 10%) remains one of the major limitations of TRA.
The aim of the study is to assess the superiority of verapamil versus heparin in the access success during transradial percutaneous coronary interventions (PCI).
METHODS Patients referred to the cath-lab of the Cardiovascular Institute of the University Hospital of Ferrara, Italy, for coronary angiography were randomized in 2 groups with a computer-generated random sequence. The study is double-blind. In the first group, patients received intravenous heparin (5000 UI) immediately after a 6 F sheath insertion. In the second group, patients received Verapamil (5 mg) immediately after a 6 F sheath insertion. If after the start of the procedure a radial artery spasm (RAS) occurs, the operators can choose to use bail-out a local vasodilator therapy. After sheath removal, hemostasis was obtained using a TR band (Terumo corporation, Tokyo, Japan) with a plethysmography-guided patent hemostasis technique. Radial artery patency was evaluated at 24 hours (early RAO) and 30 days after the procedure (late RAO) by ultrasound.
The aim of the study is to demonstrate that verapamil administration is superior to heparin administration in the reduction of the combined endpoint (occurrence of radial artery occlusion (early RAO), access site complication, radial artery spasm (RAS) requiring local bailout use of vasodilatator)
RAO will be assessed by ultrasonography by independent expert reviewer blinded to randomization
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
- Double (Participant, Investigator)
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
- •Patients admitted to hospital with diagnosis of acute coronary syndrome and stable coronary artery disease according current European guidelines and with clinical indication to coronary artery angiography.
- •all patients receiving percutaneous coronary intervention by radial artery access as first attempt
- •procedures with 6F catheter
排除标准
- •warfarin therapy
- •previous ipsilateral TRA
- •lack of consent
- •scleroderma
- •thrombocytopenia
- •or other contraindications to heparin
研究组 & 干预措施
standard of care
intraradial heparin (5000 UI) immediately after a 6 F sheath insertion
干预措施: Heparin (Drug)
experimental therapy
intraradial verapamil (5 mg) immediately after a 6 F sheath insertion
干预措施: Verapamil (Drug)
结局指标
主要结局
number of participants with radial artery-related complications
时间窗: 24 hours
occurrence of early radial artery occlusion, access site complication, radial artery spasm (RAS) that requires the bailout use of vasodilatator
次要结局
- long term patient's satisfaction(30 days)
- late radial artery occlusion(30 days)
- number of participants with each radial artery-related complication(24 hours)
- reopening early RAO(30 days)
- patient's satisfaction(24 hours)
研究者
Gianluca Campo
Assistant Professor and Interventional Cardiologist
University Hospital of Ferrara