Diclofenac for Submassive PE

Pulmonary Embolism Clinical Trial

— AINEP-1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01590342
• Other study ID #: 2012-000247-27
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: May 1, 2012
• Last updated: September 5, 2017
• Start date: May 2012
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: Ministry of Health, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Drug:
• Diclofenac
Diclofenac 75 mg, two doses
• Placebo
Placebo, two doses

Locations

Country	Name	City	State
Spain	Ramon y Cajal Hospital, IRYCIS	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular dysfunction assessed by transthoracic echocardiography		36-48 hours after administration of the first dose of diclofenac/placebo
Secondary	Right ventricular dysfunction assessed by transthoracic echocardiography		Seven days after administration of diclofenac/placebo