NCT02946944Unknown1 期
Pilot Randomized Study of the Sidlenafil Efficacy in Combination With Oral Anticoagulants in the Treatment of Patients With Intermediate-high Risk of Pulmonary Embolism
Meshalkin Research Institute of Pathology of Circulation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- MSCT RV \ LV Index
研究概览
简要总结
Pilot randomized study of the sidlenafil efficacy in combination with oral anticoagulants in the treatment of patients with intermediate-high risk of pulmonary embolism
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pulmonary embolism confirmed by CT scan with contrast, with localization of thrombusa in at least one main or proximal lobar pulmonary artery.
- •Right-left ventricular ratio (RV / LV) ≥1 derived from the apical four-chamber view
- •Who gave written informed consent to participate in research
排除标准
- •Age <18 or >80 years
- •Symptoms of pulmonary embolism> 14 days
- •Inadequate echocardiographic image quality in the apical four-chamber projection, which limits the measurement of RV / LV ratio
- •A significant risk of bleeding
- •The administration of thrombolytic drugs within the previous 4 days
- •Active bleeding
- •Known coagulopathy
- •Thrombocytopenia <100,10^9 / l
- •Previous use of vitamin K antagonists with an INR> 2.5 at admission
- •History of any intracranial or spinal surgery or trauma or intracranial / spinal bleeding
- •Intracranial neoplasm
- •Arteriovenous malformations or aneurysms
- •GIH <3 months
- •Cataract Surgery
- •Obstetrical manipulation
- •Cardiopulmonary resuscitation needed.
- •Other invasive procedures <10 days
- •Allergy, hypersensitivity, thrombocytopenia to heparin or tissue plasminogen activator
- •Allergy to iodine contrast
- •A well-known right-left cardiac shunt, for example, a large patent foramen ovale, or atrial septal defect; large (> 10 mm), or a blood clot in right atrium/right ventricle
- •Systolic blood pressure <90 mm Hg for at least 15 minutes, or fall of systolic blood pressure is not less than 40 mm Hg for at least 15 min., with evidence of organ hypoperfusion (cold extremities or low diuresis <30 mL / h, or confusion), or the need for administration of catecholamines to maintain adequate perfusion of organs and systolic blood pressure> 90 mm Hg
- •Severe hypertension (systolic> 180 mm Hg or diastolic> 105 mm Hg.).
- •Pregnancy, lactation, delivery<30 days
- •Participation in any other study (drug or device)
- •Life expectancy <90 days
- •Refusal to participate in the study
研究组 & 干预措施
double drug therapy
Experimental
干预措施: Sildenafil/apixaban (Drug)
mono drug therapy
Active Comparator
干预措施: apixaban (Drug)
结局指标
主要结局
MSCT RV \ LV Index
时间窗: 7th day
on the 7th day of treatment RV \\ LV Index (calculated according to MSCT angiography of the pulmonary arteries)
次要结局
- death(one month)
- recurrent venous thrombosis(one month)
- recurrent pulmonary embolism(one month)
- Echocardiogram pressure in the pulmonary artery(one month)
- bleeding(one month)
- hemodynamic instability(one month)
- Echocardiogram RV \ LV Index(one month)
研究者
研究点 (1)
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