Diclofenac for Submassive PE (AINEP-1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Ministry of Health, Spain
Sponsor:
Information provided by (Responsible Party):
David Jimenez, Ministry of Health, Spain
ClinicalTrials.gov Identifier:
NCT01590342
First received: May 1, 2012
Last updated: September 4, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Right ventricular dysfunction assessed by transthoracic echocardiography [ Time Frame: Seven days after administration of diclofenac/placebo ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: September 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590342

Locations
Spain
Ramon y Cajal Hospital, IRYCIS Recruiting
Madrid, Spain, 28034
Contact: David Jimenez, MD, PhD    +34669461858    djc_69_98@yahoo.com   
Sponsors and Collaborators
Ministry of Health, Spain
Investigators
Study Chair: David Jimenez, MD, PhD Ramon y Cajal Hospital, IRYCIS
  More Information

No publications provided

Responsible Party: David Jimenez, Clinical researcher, Ministry of Health, Spain
ClinicalTrials.gov Identifier: NCT01590342     History of Changes
Other Study ID Numbers: 2012-000247-27
Study First Received: May 1, 2012
Last Updated: September 4, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by 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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014