Pulmonary Embolism | Diclofenac for Submassive PE
Pulmonary Embolism research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:DiclofenacDiclofenac 75 mg, two doses
Drug:PlaceboPlacebo, two doses
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: May 2012
Completed Date: June 2017
Phase: Phase 2/Phase 3
Primary Outcome: Right ventricular dysfunction assessed by transthoracic echocardiography
Secondary Outcome: Right ventricular dysfunction assessed by transthoracic echocardiography
Study sponsors, principal investigator, and references
Principal Investigator: David Jimenez, MD, PhD
Lead Sponsor: Ministry of Health, Spain