NCT01590342终止2 期
Efficacy of Diclofenac for Patients With Acute Submassive Pulmonary Embolism: a Randomized Clinical Trial
Ministry of Health, Spain1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Right ventricular dysfunction assessed by transthoracic echocardiography
研究概览
简要总结
The primary objective is to demonstrate the clinical benefits of diclofenac (added to standard anticoagulant therapy) over placebo in normotensive patients with acute symptomatic pulmonary embolism and right ventricular dysfunction.
The secondary objective is to assess the safety after administration of diclofenac in normotensive patients with acute symptomatic pulmonary embolism and right ventricular dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute symptomatic PE confirmed by multidetector CT angiography, a high-probability V/Q scan, or by the presence of deep vein thrombosis confirmed by lower limb ultrasound testing in patients with nonconclusive V/Q scan;
- •first symptoms occurring ten days or less before randomization;
- •haemodynamic stability (systolic blood pressure > 100 mm Hg, no need of inotropic support, pulmonary resuscitation, intubation or thrombolytic treatment);
- •right ventricular dysfunction assessed by transthoracic echocardiography within the first 12 hours after diagnosis of PE;
- •signed informed consent.
排除标准
- •Previous diagnosis of chronic thromboembolic pulmonary hypertension;
- •active bleeding, or clinically relevant bleeding in the previous month before diagnosis of PE;
- •peptic ulcer;
- •major surgery, or severe trauma in the previous month before diagnosis of PE;
- •indication for chronic anticoagulation;
- •pregnancy or breast feeding;
- •renal insufficiency (serum creatinine > 2 mg/dL) or severe hepatic impairment;
- •hypersensitivity to diclofenac, sodium metabisulfite, or acetylsalicylic acid;
- •bronchial asthma;
- •severe congestive heart failure;
- •inflammatory bowel disease.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Diclofenac
Active Comparator
干预措施: Diclofenac (Drug)
结局指标
主要结局
Right ventricular dysfunction assessed by transthoracic echocardiography
时间窗: 36-48 hours after administration of the first dose of diclofenac/placebo
次要结局
- Right ventricular dysfunction assessed by transthoracic echocardiography(Seven days after administration of diclofenac/placebo)
研究者
David Jimenez
Clinical researcher
Ministry of Health, Spain
研究点 (1)
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