NCT01590342

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

4.7 years

First QC Date

May 1, 2012

Last Update Submit

September 5, 2017

Conditions

Pulmonary Embolism

Keywords

Pulmonary embolismRight ventricular dysfunctionPrognosisInflammation

Outcome Measures

Primary Outcomes (1)

  • Right ventricular dysfunction assessed by transthoracic echocardiography

    36-48 hours after administration of the first dose of diclofenac/placebo

Secondary Outcomes (1)

  • Right ventricular dysfunction assessed by transthoracic echocardiography

    Seven days after administration of diclofenac/placebo

Study Arms (2)

Diclofenac

ACTIVE COMPARATOR
Drug: Diclofenac

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DiclofenacDRUG

Diclofenac 75 mg, two doses

Diclofenac
PlaceboDRUG

Placebo, two doses

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • first symptoms occurring ten days or less before randomization;
  • haemodynamic stability (systolic blood pressure \> 100 mm Hg, no need of inotropic support, pulmonary resuscitation, intubation or thrombolytic treatment);
  • right ventricular dysfunction assessed by transthoracic echocardiography within the first 12 hours after diagnosis of PE;
  • signed informed consent.

You may not qualify if:

  • Previous diagnosis of chronic thromboembolic pulmonary hypertension;
  • active bleeding, or clinically relevant bleeding in the previous month before diagnosis of PE;
  • peptic ulcer;
  • major surgery, or severe trauma in the previous month before diagnosis of PE;
  • indication for chronic anticoagulation;
  • pregnancy or breast feeding;
  • renal insufficiency (serum creatinine \> 2 mg/dL) or severe hepatic impairment;
  • hypersensitivity to diclofenac, sodium metabisulfite, or acetylsalicylic acid;
  • bronchial asthma;
  • severe congestive heart failure;
  • inflammatory bowel disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramon y Cajal Hospital, IRYCIS

Madrid, 28034, Spain

Location

Related Publications (1)

  • Jimenez D, Nieto R, Corres J, Fernandez-Golfin C, Barrios D, Morillo R, Quezada CA, Huisman M, Yusen RD, Kline J. Diclofenac for reversal of right ventricular dysfunction in acute normotensive pulmonary embolism: A pilot study. Thromb Res. 2018 Feb;162:1-6. doi: 10.1016/j.thromres.2017.12.002. Epub 2017 Dec 5.

    PMID: 29247809DERIVED

MeSH Terms

Conditions

Pulmonary EmbolismVentricular Dysfunction, RightInflammation

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesVentricular DysfunctionHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • David Jimenez, MD, PhD

    Ramon y Cajal Hospital, IRYCIS

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical researcher

Study Record Dates

First Submitted

May 1, 2012

First Posted

May 2, 2012

Study Start

May 1, 2012

Primary Completion

January 1, 2017

Study Completion

June 1, 2017

Last Updated

September 6, 2017

Record last verified: 2017-09

Locations

ES(1)