Diclofenac for Submassive PE

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Diclofenac for Patients With Acute Submassive Pulmonary Embolism: a Randomized Clinical Trial

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Drug: Diclofenac
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; first symptoms occurring ten days or less before randomization; haemodynamic stability (systolic blood pressure > 100 mm Hg, no need of inotropic support, pulmonary resuscitation, intubation or thrombolytic treatment); right ventricular dysfunction assessed by transthoracic echocardiography within the first 12 hours after diagnosis of PE; signed informed consent. Exclusion Criteria: Previous diagnosis of chronic thromboembolic pulmonary hypertension; active bleeding, or clinically relevant bleeding in the previous month before diagnosis of PE; peptic ulcer; major surgery, or severe trauma in the previous month before diagnosis of PE; indication for chronic anticoagulation; pregnancy or breast feeding; renal insufficiency (serum creatinine > 2 mg/dL) or severe hepatic impairment; hypersensitivity to diclofenac, sodium metabisulfite, or acetylsalicylic acid; bronchial asthma; severe congestive heart failure; inflammatory bowel disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diclofenac<br> | Drug: Diclofenac<br>* Diclofenac 75 mg, two doses<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo, two doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right ventricular dysfunction assessed by transthoracic echocardiography |  | 36-48 hours after administration of the first dose of diclofenac/placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right ventricular dysfunction assessed by transthoracic echocardiography |  | Seven days after administration of diclofenac/placebo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary embolism, Right ventricular dysfunction, Prognosis, Inflammation