Clinical trial NCT01590342: Diclofenac for Submassive PE
Official title: Efficacy of Diclofenac for Patients With Acute Submassive Pulmonary Embolism: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Pulmonary Embolism
Keywords: Pulmonary embolism
Right ventricular dysfunction
Prognosis
Inflammation
Lead sponsor: Ministry of Health, Spain
Sponsor class: OTHER_GOV
First posted: 2012-05-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Right ventricular dysfunction assessed by transthoracic echocardiography
timeFrame: 36-48 hours after administration of the first dose of diclofenac/placebo
Secondary outcomes:
measure: Right ventricular dysfunction assessed by transthoracic echocardiography
timeFrame: Seven days after administration of diclofenac/placebo
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ramon y Cajal Hospital, IRYCIS
Study officials:
affiliation: Ramon y Cajal Hospital, IRYCIS
name: David Jimenez, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.