Diclofenac for Submassive PE (AINEP-1)

September 5, 2017 updated by: David Jimenez, Ministry of Health, Spain

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Ramon y Cajal Hospital, IRYCIS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo, two doses
ACTIVE_COMPARATOR: Diclofenac
Drug: Diclofenac
Diclofenac 75 mg, two doses

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Spain

Investigators

  • Study Chair: David Jimenez, MD, PhD, Ramon y Cajal Hospital, IRYCIS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

May 1, 2012

First Submitted That Met QC Criteria

May 1, 2012

First Posted (ESTIMATE)

May 2, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 5, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-000247-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Embolism

Clinical Trials on Diclofenac

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe