NCT04046029Unknown4 期
Bivalirudin vs Heparin in Elderly Patients With Acute Coronary Syndrome Undergoing Elective Percutaneous Coronary Intervention
The First Affiliated Hospital of Dalian Medical University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019年7月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute coronary syndrome undergoing elective percutaneous coronary intervention.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥75 years old;
- •Planned elective PCI for patients with acute coronary syndrome;
- •Life expectancy ≥ 1 year;
- •Provide written informed consent.
排除标准
- •Contraindications to angiography or PCI;
- •Active bleeding or bleeding constitution, bleeding tendency, including GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc;
- •Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intra-cerebral mass, aneurysm, etc.);
- •Severe renal insufficiency (eGFR < 30 mL/min/ 1.73 m2);
- •Elevated AST, ALT level higher than three times of the normal upper limit;
- •Advanced heart failure (NYHA classification grading of cardiac function ≥Ⅲ) Complicated with immune system diseases#
- •Abnormal hematopoietic system: platelet count < 100 × 109 / L or >700 × 109 / L, white blood cell count < 3×109/L etc;
- •Suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors;
- •Known intolerance, or contraindication to any antithrombotic medication
- •Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
- •Non-cardiac co-morbid conditions are present that may result in protocol non-compliance;
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
- •Patient's inability to fully cooperate with the study protocol
研究组 & 干预措施
Bivalirudin
Experimental
干预措施: Bivalirudin (Drug)
Heparin
Active Comparator
干预措施: Heparin (Drug)
结局指标
主要结局
Major adverse cardiac events
时间窗: 7 days
A composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina, Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Major bleeding
时间窗: 7 days
BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.
次要结局
- Major adverse cardiac events(180 days)
- Stent thrombosis ,TVR ,TLR(180 days)
- Major bleeding(180days)
研究者
研究点 (1)
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