In-Vitro Evaluation of Anticoagulant Therapy Management When Urgent Percutaneous Coronary Intervention is Required in Rivaroxaban-Treated Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Anticoagulation level
研究概览
简要总结
We investigated in-vitro the management of intraprocedural anticoagulation in patients requiring immediate percutaneous coronary intervention(PCI) while using regular direct oral anticoagulants(DOACs). Twenty-five patients taking 20mg of rivaroxaban once daily comprised the study group, while five healthy volunteers included the control group. In study group, a beginning(24-hours after the last rivaroxaban dose) examination was performed. Then, the effects of basal and four different anticoagulant doses(50IU/kg unfractionated heparin(UFH), 100IU/kg UFH, 0.5mg/kg enoxaparin, and 1mg/kg enoxaparin) on coagulation parameters were investigated at the 4th and 12th hours following rivaroxaban intake. Anticoagulant activity was assessed mainly by anti-factor Xa(anti-Xa) levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients using the direct oral factor Xa inhibitor rivaroxaban
- •Atrial fibrillation
排除标准
- •malignancy,
- •coagulopathy,
- •heart valve disease,
- •active infection,
- •chronic systemic or inflammatory disease,
- •recent ACS or elective PCI,
- •uncontrolled hypertension and diabetes,
- •cerebrovascular accident,
- •thyroid disorder,
- •left ventricular systolic dysfunction (ejection fraction <50%),
- •glomerular filtration rate <50 mL/min/1.73 m2,
- •underweight and overweight (<60 kg and >100 kg),
- •age >75 years,
- •hyperbilirubinemia and hypertriglyceridemia (>350 mg/dl).
研究组 & 干预措施
control group
five healthy adults
干预措施: In vitro heparin (Drug)
Study group
Twenty-five patients using the direct oral factor Xa inhibitor rivaroxaban
干预措施: In vitro heparin (Drug)
结局指标
主要结局
Anticoagulation level
时间窗: 4 - 12 hours
anti-factor Xa
次要结局
未报告次要终点
研究者
Hasan ARI
Professor Doctor
Bursa Postgraduate Hospital