Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pulmonary hypertension
研究概览
简要总结
To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic residual pulmonary hypertension.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pulmonary embolism after undergone surgical treatment (intravascular thrombolysis, catheter thrombus fragmentation)
- •Patients with preserved thromboembolism in the pulmonary circulation system and mean pressure in the pulmonary artery of more than 25 mm Hg
排除标准
- •Patient did not sign the informed consent.
- •Mean pulmonary artery pressure after surgical treatment less than 25 mm Hg
- •Age above 75 years.
- •Patients with an increased risk of bleeding - including gastric ulcer and 12 duodenal ulcer in acute, hemorrhagic stroke.
- •Severe coronary artery disease (unstable angina, myocardial infarction within the last 6 months).
- •Acute heart failure or CHF IV in NYHA.
- •Severe arrhythmias.
- •Pregnancy, lactation.
- •The presence of severe diseases of other organ systems that may result in death during the first year after surgery.
研究组 & 干预措施
Ventavis + Warfarin
Patients in this group will receive drug treatment - ventavis (2,0 ml - 6 time per day - during 5 days). Warfarin - INR=2,0-3,0
干预措施: Ventavis (Drug)
Ventavis + Warfarin
Patients in this group will receive drug treatment - ventavis (2,0 ml - 6 time per day - during 5 days). Warfarin - INR=2,0-3,0
干预措施: Warfarin (Drug)
Warfarin
Patients in this group will receive drug treatment according to up-to-date guidelines (Warfarin - INR=2,0-3,0)
干预措施: Warfarin (Drug)
结局指标
主要结局
Pulmonary hypertension
时间窗: 6 months
The average pressure in the pulmonary artery trunk (according to direct tensiometry before Ventavis therapy, after the therapy according to transthoracic echocardiography and six months after discharge (transthoracic echocardiography).
次要结局
- Number of deaths(6 months)
- Number of recurrent pulmonary embolisms(6 months)
- Number of venous thromboembolisms(6 months)