Diclofenac for Submassive PE

Phase 2

Terminated

• Conditions: Pulmonary Embolism
• Interventions: Drug: Diclofenac; Drug: Placebo

• Registration Number: NCT01590342
• Lead Sponsor: Ministry of Health, Spain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-02
• Primary Completion: 2017-01
• Study Completion: 2017-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-05
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diclofenac	Diclofenac	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Right ventricular dysfunction assessed by transthoracic echocardiography	36-48 hours after administration of the first dose of diclofenac/placebo

Secondary Outcome Measures

Name	Time	Method
Right ventricular dysfunction assessed by transthoracic echocardiography	Seven days after administration of diclofenac/placebo

Trial Locations

Locations (1)

Ramon y Cajal Hospital, IRYCIS; 🇪🇸 Madrid, Spain