ElderlyPEAGENCT02360943
Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: PEAGE
An observational study of Elderly and Pulmonary Embolism, run by Centre Hospitalier Universitaire de Saint Etienne at 20 sites in France.
Trial summary
The treatment of the venous thromboembolic disease, including pulmonary embolism (PE), is based on anticoagulants. During the last decade, all the randomized clinical trials evaluating these anticoagulants have included PE patients with an average age below 60 years. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Elderly, Pulmonary Embolism, Anticoagulants
- What is being tested?
- 4 blood samples
- How many people
- 1,500 participants
- Where
- 20 sitesFrance
- Study dates
- 9 Jul 2014to 22 Apr 2022
- Phase
- Observational
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: patients older than 75 years receiving an anticoagulant treatment (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants) for a symptomatic and confirmed pulmonary embolism
Who may be able to join
- Symptomatic pulmonary embolism confirmed by objective paraclinical examination with or without DVT associated
- confirmation of pulmonary embolism within 3 days
- Administration possible according to the recommended dosages of anticoagulant treatment : (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants)
- Indication of anticoagulant treatment for at least 6 months
Who cannot join
- on therapeutic dose of anticoagulant treatment over 72 hours
- indication to therapeutic dose of anticoagulant treatment for another reason.
- Inability for whatever reasons, to prescribe recommended anticoagulant treatment
- PE treatment on heparin-induced thrombocytopenia requiring argatroban, lepirudin or danaparoid treatment,
- ongoing bleeding
- PE occurring despite well conducted anticoagulant treatment
- Contraindications to recommended dose of anticoagulant treatment
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
CHU d'Angers
Angers, 49033
Hôpital Universitaire Jean Minjoz
Besançon, 25000
CHU de Brest
Brest, 29609
Clinique du Parc - Castelnau Le Lez
Castelnau-le-Lez, 34170
CHU Gabriel Montpied
Clermont-Ferrand, 63003
Hôpitaux Universitaires Louis Mourier Paris Nord
Colombes, 92700
CHU de Dijon
Dijon, 21079
CHU de Grenoble
Grenoble, 38043
CHU de Limoges
Limoges, 87000
CHU de Montpellier
Montpellier, 34295
CHRU de Nantes
Nantes, 44093
CHU de Nice
Nice, 06002
Hôpital Europeen Georges Pompidou, APHP
Paris, 75015
APHP Hôpital BROCA
Paris
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
CHU de Rouen
Rouen, 76000
CHU de Saint Etienne
Saint-Etienne, 42055
CHU de Strasbourg - Hôpital Civil
Strasbourg, 67000
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, 83056
CHU Tours
Tours, 37000
About this study
Official title: Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: Prospective, Multicenter Cohort Study PEAGE
The treatment of the venous thromboembolic disease, including pulmonary embolism (PE), is based on anticoagulants. During the last decade, all the randomized clinical trials evaluating these anticoagulants have included PE patients with an average age below 60 years. But in clinical pratice, approximately 50% of PE patients are older than 75 years.
So the investigators want to perform a french multicentre prospective cohort of consecutive patients receiving an anticoagulant treatment for a symptomatic and confirmed PE. All the validated and available anticoagulant treatments are authorized in this cohort (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants).
Read more
This cohort will provide data regarding the bleeding risk and the risk of PE recurrences and regarding the pharmacokinetic (PK) and pharmacodynamic (PD) properties of these anticoagulants in this older population. Using population approach modelling , the investigators will pay particular attention to the sources of PK/PD variability PK / PD such as genetic polymorphisms of P-glycoprotein and cytochrome P450.
Using all these data , the investigators will try to identify significant risk factors for bleeding and venous thromboembolic events.
- Conditions
- Elderly, Pulmonary Embolism, Anticoagulants
- Being tested
- 4 blood samples
- Keywords
- elderly patients, Pulmonary embolism, Anticoagulant treatments
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 blood samplesOther
PK and / or PD measurements during hospitalization
| Study group | Role | What they receive |
|---|---|---|
| PEAGE | Patients older than 75 years receiving an anticoagulant treatment for a symptomatic and confirmed PE Receives: Other: 4 blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major bleeding defined by the International Society of Thrombosis & Haemostasis
- Bleeding causing a fall in hemoglobin level of 20 g L-1 (1.24 mmol L-1) or more, or leading to transfusion of two or more units of whole blood or red cells.,
- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome,
- Fatal bleeding
Measured: at 6 months
Secondary outcomes (5)
Clinically relevant non-major bleeding
defined by:
- Subcutaneous hematoma spontaneous over 25 cm2
- Spontaneous epistaxis for more than 5 minutes
- Spontaneous or after urinary catheter hematuria for more than 24 hours
- Significant rectal bleeding
- Gingival bleeding for more than 5 minutes
- Bleeding requiring hospitalization and / or a hemostatic action
Measured: at 6 months
Recurrent pulmonary embolism
confirmed by CT scan or ventilation/perfusion lung scan
Measured: at 6 months
Deep vein thrombosis (recurrence or new)
confirmed by venous doppler ultrasonography or venography of the lower limbs or CT scan
Measured: at 6 months
Arterial cardiovascular events
- Acute coronary syndrom with or without ST-segment elevation
- Stroke ischemic or hemorrhagic confirmed by CT scan or magnetic resonance imaging brain
- Acute ischemic phenomena (lower limbs, mesenteric ...) confirmed by arterial doppler or arteriography.
Measured: at 6 months
Death
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study start9 Jul 2014
- Primary completion15 Oct 2021
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Patrick MISMETTI, MD PhD, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360943
- Sponsor's protocol ID
- 1208182
- Other IDs
- 2013-000315-24
- Acronym
- PEAGE
- Status last verified
- Aug 2022
- First submitted
- 6 Feb 2015
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: Prospective, Multicenter Cohort Study PEAGE
- ClinicalTrials.gov ID
- NCT02360943
- Acronym / sponsor ID
- PEAGE / 1208182
- Conditions
- Elderly, Pulmonary Embolism, Anticoagulants
- Keywords
- elderly patients, Pulmonary embolism, Anticoagulant treatments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 9 Jul 2014 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 11 Feb 2015 (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 treatment of the venous thromboembolic disease, including pulmonary embolism (PE), is based on anticoagulants. During the last decade, all the randomized clinical trials evaluating these anticoagulants have included PE patients with an average age below 60 years. But in clinical pratice, approximately 50% of PE patients are older than 75 years.
So the investigators want to perform a french multicentre prospective cohort of consecutive patients receiving an anticoagulant treatment for a symptomatic and confirmed PE. All the validated and available anticoagulant treatments are authorized in this cohort (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants).
This cohort will provide data regarding the bleeding risk and the risk of PE recurrences and regarding the pharmacokinetic (PK) and pharmacodynamic (PD) properties of these anticoagulants in this older population. Using population approach modelling , the investigators will pay particular attention to the sources of PK/PD variability PK / PD such as genetic polymorphisms of P-glycoprotein and cytochrome P450.
Using all these data , the investigators will try to identify significant risk factors for bleeding and venous thromboembolic events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEAGE | – | Other: 4 blood samplesPatients older than 75 years receiving an anticoagulant treatment for a symptomatic and confirmed PE |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients older than 75 years receiving an anticoagulant treatment (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants) for a symptomatic and confirmed pulmonary embolism
Key inclusion criteria (4 listed)
- Symptomatic pulmonary embolism confirmed by objective paraclinical examination with or without DVT associated
- confirmation of pulmonary embolism within 3 days
- Administration possible according to the recommended dosages of anticoagulant treatment : (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants)
- Indication of anticoagulant treatment for at least 6 months
Key exclusion criteria (7 listed)
- on therapeutic dose of anticoagulant treatment over 72 hours
- indication to therapeutic dose of anticoagulant treatment for another reason.
- Inability for whatever reasons, to prescribe recommended anticoagulant treatment
- PE treatment on heparin-induced thrombocytopenia requiring argatroban, lepirudin or danaparoid treatment,
- ongoing bleeding
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 |
|---|---|---|
| 4 blood samplesPK and / or PD measurements during hospitalization | Other | PEAGE |
Primary outcome
Major bleeding defined by the International Society of Thrombosis & Haemostasis
Time frame: at 6 months
* Bleeding causing a fall in hemoglobin level of 20 g L-1 (1.24 mmol L-1) or more, or leading to transfusion of two or more units of whole blood or red cells., * Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, * Fatal bleeding
5 secondary outcomes
Clinically relevant non-major bleeding
Time frame: at 6 months
Recurrent pulmonary embolism
Time frame: at 6 months
Deep vein thrombosis (recurrence or new)
Time frame: at 6 months
Arterial cardiovascular events
Time frame: at 6 months
Death
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Patrick MISMETTI, MD PhD principal investigator
CHU de Saint Etienne
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly and Pulmonary Embolism, run by Centre Hospitalier Universitaire de Saint Etienne at 20 sites in France.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Major bleeding defined by the International Society of Thrombosis & Haemostasis (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2022.