Safety and Efficacy of Bivalirudin in Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention (PCI)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 主要终点
- activated clotting time(ACT)
研究概览
简要总结
Bivalirudin is widely used as an anticoagulant to reduce the risk of bleeding in PCI perioperative period. Additionally, 15.7%-32.7% patients have diabetes mellitus who undergo percutaneous coronary interventions (PCI), so bivalirudin was used to anticoagulate in these patients to evaluate its safety and efficacy.
详细描述
Bivalirudin is a specific reversible thrombin direct inhibitor and the function of thrombin activity site can be recovered through hydrolyzing bivalirudin by thrombin. Therefore, bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (PCI) for coronary heart disease, and 15.7%-32.7% patients have diabetes mellitus who undergo percutaneous coronary interventions (PCI). At the same time, elderly patients have higher risk of bleeding whose age over 65, so bivalirudin can reduce the risk of bleeding and the incidence of net adverse clinical events for the elderly patients whose age over 65 with diabetes mellitus in PCI perioperative period.
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
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 65 years, with diabetes mellitus.
- •Patients who undergo selective PCI therapy.
- •Patients who agree to participate in this clinical trial and sign informed consent prior to surgery.
排除标准
- •Patients with acute coronary syndrome undergoing primary PCI.
- •Combined with other diseases, the life expectancy of patients don't exceed 1 year.
- •Patients with active bleeding.
- •Bleeding in the gastrointestinal or urogenital tract in the past 6 weeks.
- •Combined with high risk of postoperative hemorrhage, such as active gastric ulcer, active ulcerative colitis, etc.
- •Patients who have undergone major surgery in the last 1 month.
- •A history of intracranial bleeding or structural abnormalities, such as cerebral aneurysms.
- •Patients with cardiogenic shock, or suspected myocarditis, infective endocarditis.
- •Patients who received regular heparin therapy within 6 hours or low molecular weight heparin therapy within 8 hours, or other factors that the researchers believe may influence the outcome of the trial.
- •Patients with severe uncontrolled hypertension.
- •Patients with active hepatitis, HIV and other infectious diseases.
- •Patients with contraindications of bivalirudin and heparin.
- •Other researchers considered the patients are unfit to participate in this study.
研究组 & 干预措施
Selective PCI with bivalirudin
Before PCI, bivalirudin is intravenously injected with 0.75 mg/kg, 1.75 mg/(kg.h) through continuous intravenous drip to finish surgery (no more than 4 hours), if necessary, after the surgery, with a low dose of 0.2 mg/(kg.h) intravenous drip less than 20 hours.
干预措施: Selective PCI (Procedure)
Selective PCI with bivalirudin
Before PCI, bivalirudin is intravenously injected with 0.75 mg/kg, 1.75 mg/(kg.h) through continuous intravenous drip to finish surgery (no more than 4 hours), if necessary, after the surgery, with a low dose of 0.2 mg/(kg.h) intravenous drip less than 20 hours.
干预措施: Bivalirudin (Drug)
Unfractionated heparin
Before PCI, unfractionated heparin sodium is intravenously injected with 70-100 U/kg, and if the operation time exceeded 1h, an additional 1000 U/h would be added.
干预措施: Selective PCI (Procedure)
结局指标
主要结局
activated clotting time(ACT)
时间窗: 5min after using drug
The ACT test can be used to monitor anticoagulation effects, such as high-dose heparin before, during, and shortly after procedures that require intense anticoagulant administration, such as cardiac bypass, cardiac angioplasty, thrombolysis, extra-corporeal membrane oxygenation (ECMO) and continuous dialysis
次要结局
- 30-day bleeding events(30 days)
- 30-day major adverse cardiac events(30 days)
研究者
Qian Gong
Principal Investigator
Mianyang Central Hospital