Diclofenac for Submassive PE (AINEP-1)

Ministry of Health, Spain

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Pulmonary Embolism

Treatments: Drug: Diclofenac; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01590342

2012-000247-27

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

Diclofenac

Active Comparator group

Treatment:

Drug: Diclofenac

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo