Pulmonary Embolism
Conditions
Keywords
Pulmonary embolism, Right ventricular dysfunction, Prognosis, Inflammation
Brief summary
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.
Interventions
DRUGDiclofenac
Diclofenac 75 mg, two doses
DRUGPlacebo
Placebo, two doses
Sponsors
Ministry of Health, Spain
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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; 2. first symptoms occurring ten days or less before randomization; 3. haemodynamic stability (systolic blood pressure \> 100 mm Hg, no need of inotropic support, pulmonary resuscitation, intubation or thrombolytic treatment); 4. right ventricular dysfunction assessed by transthoracic echocardiography within the first 12 hours after diagnosis of PE; 5. signed informed consent.
Exclusion criteria
1. Previous diagnosis of chronic thromboembolic pulmonary hypertension; 2. active bleeding, or clinically relevant bleeding in the previous month before diagnosis of PE; 3. peptic ulcer; 4. major surgery, or severe trauma in the previous month before diagnosis of PE; 5. indication for chronic anticoagulation; 6. pregnancy or breast feeding; 7. renal insufficiency (serum creatinine \> 2 mg/dL) or severe hepatic impairment; 8. hypersensitivity to diclofenac, sodium metabisulfite, or acetylsalicylic acid; 9. bronchial asthma; 10. severe congestive heart failure; 11. inflammatory bowel disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Right ventricular dysfunction assessed by transthoracic echocardiography | 36-48 hours after administration of the first dose of diclofenac/placebo |
Secondary
| Measure | Time frame |
|---|---|
| Right ventricular dysfunction assessed by transthoracic echocardiography | Seven days after administration of diclofenac/placebo |
Countries
Spain
Outcome results
None listed