Diclofenac for Submassive PE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Diclofenac

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

Diclofenac 75 mg, two doses

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, two doses

Interventions

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Diclofenac

Diclofenac 75 mg, two doses

Intervention Type DRUG

Placebo

Placebo, two doses

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No