Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: PEAGE
NCT ID: NCT02360943
Last Updated: 2022-08-25
Study Results
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Basic Information
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COMPLETED
1500 participants
OBSERVATIONAL
2014-07-09
2022-04-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PEAGE
Patients older than 75 years receiving an anticoagulant treatment for a symptomatic and confirmed PE
4 blood samples
PK and / or PD measurements during hospitalization
Interventions
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4 blood samples
PK and / or PD measurements during hospitalization
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
75 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Patrick MISMETTI, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint Etienne
Locations
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CHU d'Angers
Angers, , France
Hôpital Universitaire Jean Minjoz
Besançon, , France
CHU de Brest
Brest, , France
Clinique du Parc - Castelnau Le Lez
Castelnau-le-Lez, , France
CHU Gabriel Montpied
Clermont-Ferrand, , France
Hôpitaux Universitaires Louis Mourier Paris Nord
Colombes, , France
CHU de Dijon
Dijon, , France
CHU de Grenoble
Grenoble, , France
CHU de Limoges
Limoges, , France
CHU de Montpellier
Montpellier, , France
CHRU de Nantes
Nantes, , France
CHU de Nice
Nice, , France
Hôpital Europeen Georges Pompidou, APHP
Paris, , France
APHP Hôpital BROCA
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de Rouen
Rouen, , France
CHU de Saint Etienne
Saint-Etienne, , France
CHU de Strasbourg - Hôpital Civil
Strasbourg, , France
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, , France
CHU Tours
Tours, , France
Countries
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Other Identifiers
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2013-000315-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1208182
Identifier Type: -
Identifier Source: org_study_id
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