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

INTERVENTION: 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) Concentration type: equal Concentration number: 75‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Acute pulmonary embolism ; MedDRA version: 14.1 Level: PT Classification code 10037377 Term: Pulmonary embolism System Organ Class: 10038738 ‐ Respiratory, thoracic and mediastinal disorders Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: to demonstrate the clinical benefits of diclofenac over placebo 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 Secondary Objective: to assess the safety after administration of diclofenac in normotensive patients with acute symptomatic pulmonary embolism and right ventricular dysfunction Timepoint(s) of evaluation of this end point: 36‐48h SECONDARY OUTCOME: 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 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: