Clinical trial NCT02360943: Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: PEAGE
Official title: Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: Prospective, Multicenter Cohort Study PEAGE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly
Pulmonary Embolism
Anticoagulants
Keywords: elderly patients
Pulmonary embolism
Anticoagulant treatments
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2015-02-11
Enrollment: 1500
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Major bleeding defined by the International Society of Thrombosis & Haemostasis
timeFrame: at 6 months
Secondary outcomes:
measure: Clinically relevant non-major bleeding
timeFrame: at 6 months
measure: Recurrent pulmonary embolism
timeFrame: at 6 months
measure: Deep vein thrombosis (recurrence or new)
timeFrame: at 6 months
measure: Arterial cardiovascular events
timeFrame: at 6 months
measure: Death
timeFrame: at 6 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Besancon
country: France
facility: Hôpital Universitaire Jean Minjoz
city: Brest
country: France
facility: CHU de Brest
city: Castelnau Le Lez
country: France
facility: Clinique du Parc - Castelnau Le Lez
city: Clermont Ferrand
country: France
facility: CHU Gabriel Montpied
city: Colombes
country: France
facility: Hôpitaux Universitaires Louis Mourier Paris Nord
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU de Grenoble
city: Limoges
country: France
facility: CHU de Limoges
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nantes
country: France
facility: CHRU de Nantes
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Hôpital Europeen Georges Pompidou, APHP
city: Paris
country: France
facility: APHP Hôpital BROCA
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rouen
country: France
facility: CHU de Rouen
city: Saint Etienne Cedex
country: France
facility: CHU de Saint Etienne
city: Strasbourg
country: France
facility: CHU de Strasbourg - Hôpital Civil
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: CHU de Saint Etienne
name: Patrick MISMETTI, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: