Clinical benefit of diclofenac in patients with acute submassive pulmonary embolism: a randomized clinical trial

Fundación Investigación Hospital Ramón y Cajal0 个研究点开始时间: 2012年1月31日最近更新: 2016年8月8日

试验速览

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•1) Acute symptomatic PE confirmed by multidetector CT angiography, a high-probability V/Q scan, orbythepresence of deep vein trombosis confirmed by lower limb ultrasound testing in patients with non conclusive V/Q scan;
•2) first symptoms occurring ten days o rless before randomization;
•3) haemodynamic stability (systolic blood pressure> 100 mm Hg, no need of inotropic support, pulmonary resuscitation, intubation o rthrombolytic treatment;
•4) right ventricular dysfunction assessed by transthoracic echocardiography within the first 12 hours after diagnosis of PE;
•5) women of childbearing age should get a negative pregnancy test at screening visit; further agree to use adequate contraception (among them are considered: double barrier as condom + diaphragm, surgical sterilization) within 14 days following administration of study drug.
•6) signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) Previous diagnosis of chronic thromboembolic pulmonary hypertension;
•2) active bleeding, or clinically relevan tbleeding in the previous month before diagnosis of PE;
•4) major surgery, or severe trauma in the previous month before diagnosis of PE;
•5) indication for chronic anticoagulation;
•6) pregnancy o breast feeding;
•7) rena linsufficiency (serum creatinine > 2 mg/dL) or severe hepatic impairment;
•8) hypersensitivity to diclofenac, sodium metabisulfite, or acetilsalicilic acid.
•7) active Crohn's disease
•8) active ulcerative colitis
•9) severe heart failure
•10) a history of bronchial asthma
•11) Patients with severe renal dysfunction
•12) Patients with severe hepatic impairment
•14) Patients with coagulation disorders.
•15) A history of gastrointestinal bleeding or perforation related to previous treatment with nonsteroidal antiinflammatory drugs (NSAIDs)
•16) peptic ulcer / active GI bleeding or recurrent (two or more distinct episodes of proven ulceration or bleeding).
•17) Severe heart failure

发起方

Fundación Investigación Hospital Ramón y Cajal