Acute pulmonary embolism MedDRA version: 14.1 Level: PT Classification code 10037377 Term: Pulmonary embolism System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Voltaren
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: DICLOFENAC
CAS Number: 15307-86-5
Other descriptive name: VOLTAREN
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Fundación Investigación Hospital Ramón y Cajal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to demonstrate the clinical benefits of diclofenac over placebo in normotensive patients with acute symptomatic pulmonary embolism and right ventricular dysfunction.;Secondary Objective: to assess the safety after administration of diclofenac in normotensive patients with acute symptomatic pulmonary embolism and right ventricular dysfunction;Primary end point(s): Right ventricular dysfunction (assessed by transthroacic echocardiography) within 36-48 hours after administration of the first dose of diclofenac/placebo;Timepoint(s) of evaluation of this end point: 36-48h | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Right ventricular dysfunction (assessed by transthroacic echocardiography) within 7 days after administration of the first dose of diclofenac/placebo;Timepoint(s) of evaluation of this end point: Day 7 | — |
Countries
Spain
Contacts
Public ContactFundación Investigación Hospital Ra
Fundacion Investigación Hospital Ramón y Cajal
Outcome results
None listed