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Diclofenac for Submassive PE

Information source: Ministry of Health, Spain
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Embolism

Intervention: Diclofenac (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Ministry of Health, Spain

Official(s) and/or principal investigator(s):
David Jimenez, MD, PhD, Study Chair, Affiliation: Ramon y Cajal Hospital, IRYCIS

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Right ventricular dysfunction assessed by transthoracic echocardiography

Secondary outcome: Right ventricular dysfunction assessed by transthoracic echocardiography

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Ramon y Cajal Hospital, IRYCIS, Madrid 28034, Spain; Recruiting
David Jimenez, MD, PhD, Phone: +34669461858, Email: djc_69_98@yahoo.com
Additional Information

Starting date: May 2012
Last updated: September 4, 2014

Page last updated: August 23, 2015

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