Pulmonary EmbolismPhase 2/3AINEP-1NCT01590342
Diclofenac for Submassive PE
A Phase 2/3 study testing Diclofenac in people with Pulmonary Embolism, run by Ministry of Health, Spain at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Diclofenac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- May 2012to Jun 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Diclofenac for Patients With Acute Submassive Pulmonary Embolism: a Randomized Clinical Trial
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.
- Conditions
- Pulmonary Embolism
- Being tested
- Diclofenac, Placebo
- Keywords
- Pulmonary embolism, Right ventricular dysfunction, Prognosis, Inflammation
- Medical subject headings
- Pulmonary Embolism, Ventricular Dysfunction, Right, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
Diclofenac 75 mg, two doses
PlaceboDrug
Placebo, two doses
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac | Active comparator | Not described Receives: Drug: Diclofenac |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular dysfunction assessed by transthoracic echocardiography
Measured: 36-48 hours after administration of the first dose of diclofenac/placebo
Secondary outcomes (1)
Right ventricular dysfunction assessed by transthoracic echocardiography
Measured: Seven days after administration of diclofenac/placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2017
- Study completionJun 2017
Why it stopped: Low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Spain
- Sponsor type
- Other government
- Responsible party
- Principal investigator, David Jimenez, Ministry of Health, Spain
- Investigators
- David Jimenez, MD, PhD, Study chair, Ramon y Cajal Hospital, IRYCIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590342
- Sponsor's protocol ID
- 2012-000247-27
- Acronym
- AINEP-1
- Status last verified
- Sep 2017
- First submitted
- 1 May 2012
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29247809
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diclofenac for Patients With Acute Submassive Pulmonary Embolism: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01590342
- Acronym / sponsor ID
- AINEP-1 / 2012-000247-27
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary embolism, Right ventricular dysfunction, Prognosis, Inflammation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ministry of Health, SpainOther government
- Study start
- May 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac | Active comparator | Drug: Diclofenac |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiclofenacDiclofenac 75 mg, two doses | Drug | Diclofenac |
| PlaceboPlacebo, two doses | Drug | Placebo |
Primary outcome
Right ventricular dysfunction assessed by transthoracic echocardiography
Time frame: 36-48 hours after administration of the first dose of diclofenac/placebo
1 secondary outcome
Right ventricular dysfunction assessed by transthoracic echocardiography
Time frame: Seven days after administration of diclofenac/placebo
Results and safety
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Derived from this study: PubMed 29247809Jimenez 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.
Related trials for Pulmonary Embolism
Not yet recruiting
Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study
Atrial Fibrillation (AF), Pulmonary Embolism (PE)
RecruitingObservational study
A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism
Acute Pulmonary Embolism
Not yet recruitingPhase 2
Phase IIA Study of Belzutifan in EPAS1-, EGLN1-, or VHL-Mutant Erythrocytosis
Erythrocytosis, Pulmonary Hypertension
Active, not recruitingObservational study
Epidemiology of Venous Thrombosis and Pulmonary Embolism
Cardiovascular Diseases, Pulmonary Embolism
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Jimenez, MD, PhD study chair
Ramon y Cajal Hospital, IRYCIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Diclofenac in people with Pulmonary Embolism, run by Ministry of Health, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular dysfunction assessed by transthoracic echocardiography (time frame: 36-48 hours after administration of the first dose of diclofenac/placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01590342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.