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
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