Diclofenac for Submassive PE (AINEP-1)
Primary Purpose
Pulmonary Embolism
Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Diclofenac
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Embolism focused on measuring Pulmonary embolism, Right ventricular dysfunction, Prognosis, Inflammation
Eligibility Criteria
Inclusion Criteria:
- 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;
- first symptoms occurring ten days or less before randomization;
- haemodynamic stability (systolic blood pressure > 100 mm Hg, no need of inotropic support, pulmonary resuscitation, intubation or thrombolytic treatment);
- right ventricular dysfunction assessed by transthoracic echocardiography within the first 12 hours after diagnosis of PE;
- signed informed consent.
Exclusion Criteria:
- Previous diagnosis of chronic thromboembolic pulmonary hypertension;
- active bleeding, or clinically relevant bleeding in the previous month before diagnosis of PE;
- peptic ulcer;
- major surgery, or severe trauma in the previous month before diagnosis of PE;
- indication for chronic anticoagulation;
- pregnancy or breast feeding;
- renal insufficiency (serum creatinine > 2 mg/dL) or severe hepatic impairment;
- hypersensitivity to diclofenac, sodium metabisulfite, or acetylsalicylic acid;
- bronchial asthma;
- severe congestive heart failure;
- inflammatory bowel disease.
Sites / Locations
- Ramon y Cajal Hospital, IRYCIS
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Diclofenac
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Right ventricular dysfunction assessed by transthoracic echocardiography
Secondary Outcome Measures
Right ventricular dysfunction assessed by transthoracic echocardiography
Full Information
NCT ID
NCT01590342
First Posted
May 1, 2012
Last Updated
September 5, 2017
Sponsor
Ministry of Health, Spain
1. Study Identification
Unique Protocol Identification Number
NCT01590342
Brief Title
Diclofenac for Submassive PE
Acronym
AINEP-1
Official Title
Efficacy of Diclofenac for Patients With Acute Submassive Pulmonary Embolism: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment rate
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Spain
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Pulmonary embolism, Right ventricular dysfunction, Prognosis, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diclofenac
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Description
Diclofenac 75 mg, two doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, two doses
Primary Outcome Measure Information:
Title
Right ventricular dysfunction assessed by transthoracic echocardiography
Time Frame
36-48 hours after administration of the first dose of diclofenac/placebo
Secondary Outcome Measure Information:
Title
Right ventricular dysfunction assessed by transthoracic echocardiography
Time Frame
Seven days after administration of diclofenac/placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
first symptoms occurring ten days or less before randomization;
haemodynamic stability (systolic blood pressure > 100 mm Hg, no need of inotropic support, pulmonary resuscitation, intubation or thrombolytic treatment);
right ventricular dysfunction assessed by transthoracic echocardiography within the first 12 hours after diagnosis of PE;
signed informed consent.
Exclusion Criteria:
Previous diagnosis of chronic thromboembolic pulmonary hypertension;
active bleeding, or clinically relevant bleeding in the previous month before diagnosis of PE;
peptic ulcer;
major surgery, or severe trauma in the previous month before diagnosis of PE;
indication for chronic anticoagulation;
pregnancy or breast feeding;
renal insufficiency (serum creatinine > 2 mg/dL) or severe hepatic impairment;
hypersensitivity to diclofenac, sodium metabisulfite, or acetylsalicylic acid;
bronchial asthma;
severe congestive heart failure;
inflammatory bowel disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Jimenez, MD, PhD
Organizational Affiliation
Ramon y Cajal Hospital, IRYCIS
Official's Role
Study Chair
Facility Information:
Facility Name
Ramon y Cajal Hospital, IRYCIS
City
Madrid
ZIP/Postal Code
28034
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
29247809
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.
Results Reference
derived
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Diclofenac for Submassive PE
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