Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: PEAGE
PEAGE
2 other identifiers
observational
1,500
1 country
20
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2014
CompletedFirst Submitted
Initial submission to the registry
February 6, 2015
CompletedFirst Posted
Study publicly available on registry
February 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2022
CompletedAugust 25, 2022
August 1, 2022
7.3 years
February 6, 2015
August 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
at 6 months
Secondary Outcomes (5)
Clinically relevant non-major bleeding
at 6 months
Recurrent pulmonary embolism
at 6 months
Deep vein thrombosis (recurrence or new)
at 6 months
Arterial cardiovascular events
at 6 months
Death
at 6 months
Study Arms (1)
PEAGE
Patients older than 75 years receiving an anticoagulant treatment for a symptomatic and confirmed PE
Interventions
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
CHU d'Angers
Angers, 49033, France
Hôpital Universitaire Jean Minjoz
Besançon, 25000, France
CHU de Brest
Brest, 29609, France
Clinique du Parc - Castelnau Le Lez
Castelnau-le-Lez, 34170, France
CHU Gabriel Montpied
Clermont-Ferrand, 63003, France
Hôpitaux Universitaires Louis Mourier Paris Nord
Colombes, 92700, France
CHU de Dijon
Dijon, 21079, France
CHU de Grenoble
Grenoble, 38043, France
CHU de Limoges
Limoges, 87000, France
CHU de Montpellier
Montpellier, 34295, France
CHRU de Nantes
Nantes, 44093, France
CHU de Nice
Nice, 06002, France
Hôpital Europeen Georges Pompidou, APHP
Paris, 75015, France
APHP Hôpital BROCA
Paris, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
CHU de Rouen
Rouen, 76000, France
CHU de Saint Etienne
Saint-Etienne, 42055, France
CHU de Strasbourg - Hôpital Civil
Strasbourg, 67000, France
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, 83056, France
CHU Tours
Tours, 37000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick MISMETTI, MD PhD
CHU de Saint Etienne
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2015
First Posted
February 11, 2015
Study Start
July 9, 2014
Primary Completion
October 15, 2021
Study Completion
April 22, 2022
Last Updated
August 25, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share