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Diclofenac for Submassive PE (AINEP-1)

This study has been terminated.
(Low recruitment rate)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01590342
First Posted: May 2, 2012
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Jimenez, Ministry of Health, Spain
  Purpose

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.


Condition Intervention Phase
Pulmonary Embolism Drug: Diclofenac Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Diclofenac for Patients With Acute Submassive Pulmonary Embolism: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by David Jimenez, Ministry of Health, Spain:

Primary Outcome Measures:
  • Right ventricular dysfunction assessed by transthoracic echocardiography [ Time Frame: 36-48 hours after administration of the first dose of diclofenac/placebo ]

Secondary Outcome Measures:
  • Right ventricular dysfunction assessed by transthoracic echocardiography [ Time Frame: Seven days after administration of diclofenac/placebo ]

Enrollment: 34
Study Start Date: May 2012
Study Completion Date: June 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Diclofenac Drug: Diclofenac
Diclofenac 75 mg, two doses
Placebo Comparator: Placebo Drug: Placebo
Placebo, two doses

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590342


Locations
Spain
Ramon y Cajal Hospital, IRYCIS
Madrid, Spain, 28034
Sponsors and Collaborators
Ministry of Health, Spain
Investigators
Study Chair: David Jimenez, MD, PhD Ramon y Cajal Hospital, IRYCIS
  More Information

Responsible Party: David Jimenez, Clinical researcher, Ministry of Health, Spain
ClinicalTrials.gov Identifier: NCT01590342     History of Changes
Other Study ID Numbers: 2012-000247-27
First Submitted: May 1, 2012
First Posted: May 2, 2012
Last Update Posted: September 6, 2017
Last Verified: September 2017

Keywords provided by David Jimenez, Ministry of Health, Spain:
Pulmonary embolism
Right ventricular dysfunction
Prognosis
Inflammation

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action