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Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: PEAGE (PEAGE)

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ClinicalTrials.gov Identifier: NCT02360943
Recruitment Status : Recruiting
First Posted : February 11, 2015
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment
Elderly Pulmonary Embolism Anticoagulants Other: 4 blood samples

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: Prospective, Multicenter Cohort Study PEAGE
Actual Study Start Date : July 9, 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PEAGE
Patients older than 75 years receiving an anticoagulant treatment for a symptomatic and confirmed PE
Other: 4 blood samples
PK and / or PD measurements during hospitalization




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Clinically relevant non-major bleeding [ Time Frame: at 6 months ]

    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

  2. Recurrent pulmonary embolism [ Time Frame: at 6 months ]
    confirmed by CT scan or ventilation/perfusion lung scan

  3. Deep vein thrombosis (recurrence or new) [ Time Frame: at 6 months ]
    confirmed by venous doppler ultrasonography or venography of the lower limbs or CT scan

  4. Arterial cardiovascular events [ Time Frame: at 6 months ]
    • 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.

  5. Death [ Time Frame: at 6 months ]


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360943


Contacts
Contact: Patrick MISMETTI, MD PhD 0477120285 ext +33 patrick.mismetti@chu-st-etienne.fr

Locations
France
CHU d'Angers Recruiting
Angers, France, 49033
Contact: Pierre Marie ROY, MD PhD    02 41 35 37 18 ext +33    PMRoy@chu-angers.fr   
Principal Investigator: Pierre Marie ROY, MD PhD         
Sub-Investigator: Noémie LELOUP, MD         
Sub-Investigator: Caroline SOULIE-CHAVIGNON, MD         
Sub-Investigator: David HUGLA, MD         
Sub-Investigator: Bruno CARNEIRO, MD         
Sub-Investigator: David HAMDAN, MD         
Sub-Investigator: Antoine BRANGIER, MD         
Sub-Investigator: Betty MAZET, MD         
Sub-Investigator: Cédric ANNWEILER, MD PhD         
Sub-Investigator: Christian LAVIGNE, MD PhD         
Sub-Investigator: Guillaume DUVAL, MD         
Sub-Investigator: Jean BARRE, MD         
Sub-Investigator: Marie Rita ANDREU, MD         
Sub-Investigator: Pierre-Yves PARE, MD PhD         
Sub-Investigator: Raphaëlle HUREAUX-HUYNH, MD         
Sub-Investigator: Thomas MOUMNEH, MD         
Sub-Investigator: Angélique BACHELET, MD         
Sub-Investigator: Rosen CREN, MD         
Sub-Investigator: Emilie FRIOU, MD         
Sub-Investigator: Thibault SCHOTTE, MD         
Sub-Investigator: Hélène RIVIERE, MD         
Sub-Investigator: Pierre LOZAC'H, MD         
Sub-Investigator: Hélène MEYTADIER, MD         
Sub-Investigator: Vincent AZZOLA, MD         
Hôpital Universitaire Jean Minjoz Not yet recruiting
Besancon, France, 25000
Contact: Nicolas MENNEVEAU, MD PhD    03 81 66 86 24 ext +33    nicolas.meneveau@univ-fcomte.fr   
Principal Investigator: Nicolas MENNEVEAU, MD PhD         
CHU de Brest Recruiting
Brest, France, 29609
Contact: Dominique MOTTIER, MD PhD    02 98 34 73 36 ext +33    dominique.mottier@chu-brest.fr   
Sub-Investigator: Dominique MOTTIER, MD PhD         
Sub-Investigator: Karine LACUT, MD PhD         
Principal Investigator: Francis COUTURAUD, MD PhD         
Sub-Investigator: Aurélien DELLUC, MD         
Sub-Investigator: Cécile TROMEUR, MD         
Sub-Investigator: Grégoire LE GAL, MD PhD         
Sub-Investigator: Norbert ANDRE, MD         
Sub-Investigator: Aude BARNIER, MD         
Sub-Investigator: Amélie BAZIRE, MD         
Sub-Investigator: Christophe GUT-GOBERT, MD         
Sub-Investigator: Nolwenn ASTRUC, MD         
Sub-Investigator: Emmanuelle LE MOIGNE, MD         
Sub-Investigator: Laurent SIMONIN, MD         
Sub-Investigator: Raphaël LE MAO, MD         
Clinique du Parc - Castelnau Le Lez Recruiting
Castelnau Le Lez, France, 34170
Contact: Dominique BRISOT, MD         
Principal Investigator: Dominique BRISOT, MD         
Sub-Investigator: Aurélie KHAU VAN KIEN, MD         
Sub-Investigator: Yoann THIBOUT, MD         
CHU Gabriel Montpied Active, not recruiting
Clermont Ferrand, France, 63003
Hôpitaux Universitaires Louis Mourier Paris Nord Recruiting
Colombes, France, 92700
Contact: Isabelle MAHE, MD PhD    01 47 60 64 90 ext +33    isabelle.mahe@lmr.aphp.fr   
Principal Investigator: Isabelle MAHE, MD PhD         
Sub-Investigator: Marie-Cécile COURTOIS, MD         
Sub-Investigator: Aude ROSSI, MD         
Sub-Investigator: Caroline FOURGEAUD, MD         
Sub-Investigator: Maxime DELRUE, MD         
Sub-Investigator: Sylvie GUINEMER, MD         
Sub-Investigator: Louis JOURNEAU, MD         
CHU de Dijon Not yet recruiting
Dijon, France, 21079
Contact: Nicolas FALVO, MD    03 80 29 34 32 ext +33      
Principal Investigator: Nicolas FALVO, MD         
Sub-Investigator: Sabine BERTHIER, MD         
CHU de Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Gilles PERNOD, MD PhD    04 76 76 57 17 ext +33    GPernod@chu-grenoble.fr   
Principal Investigator: Gilles PERNOD, MD PhD         
Sub-Investigator: Maxime MAIGNAN, MD         
Sub-Investigator: Sophie BLAISE, MD         
Sub-Investigator: Anne LEDOYEN-JANKOWSKI, MD         
CHU de Limoges Recruiting
Limoges, France, 87000
Contact: Philippe LACROIX, MD PhD         
Principal Investigator: Philippe LACROIX, MD PhD         
CHU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Isabelle QUERE, MD PhD    04.67.33.70.25 ext +33    i-quere@chu-montpellier.fr   
Principal Investigator: Isabelle QUERE, MD PhD         
Sub-Investigator: Aurore FANDOS BLANQUIER, MD         
Sub-Investigator: Emilie VALDELIEVRE, MD         
Sub-Investigator: Jean-Philippe GALANAUD, MD         
Sub-Investigator: Lorris LE COLLEN, MD         
Sub-Investigator: Pauline LHORTE, MD         
Sub-Investigator: Yacine RABAH, MD         
CHRU de Nantes Recruiting
Nantes, France, 44093
Contact: Gilles BERRUT, MD PhD    02 40 68 66 68 ext +33    gilles.berrut@chu-nantes.fr   
Principal Investigator: Gilles BERRUT, MD PhD         
Sub-Investigator: Pascal CHEVALET, MD PhD         
Sub-Investigator: Typhaine RIAUDEL, MD         
Sub-Investigator: Marie-Hélène FIX, MD         
CHU de Nice Not yet recruiting
Nice, France, 06002
Contact: Emile FERRARI, MD PhD    04.92.03.78.54 ext +33    ferrari.e@chu-nice.fr   
Principal Investigator: Emile FERRARI, MD PhD         
Sub-Investigator: Olivier CHICHE, MD         
Sub-Investigator: Priscille BOUVIER, MD         
Sub-Investigator: Nassim REDJIMI, MD         
Hôpital Europeen Georges Pompidou, APHP Recruiting
Paris, France, 75015
Contact: Guy MEYER, MD PhD    01 56 09 34 62 ext +33    guy.meyer@egp.aphp.fr   
Sub-Investigator: Jean PASTRE, MD         
Sub-Investigator: Olivier SANCHEZ, MD PhD         
Sub-Investigator: Benjamin PLANQUETTE, MD         
Sub-Investigator: Aude GIBELIN, MD         
Sub-Investigator: Guillaume BRIEND, MD         
Principal Investigator: Guy MEYER, MD PhD         
Sub-Investigator: Jonathan MAREY, MD         
Sub-Investigator: Anne ROCHE, MD         
APHP Hôpital BROCA Recruiting
Paris, France
Contact: Olivier HANON, MD PhD    (0)144083503 ext +33    olivier.hanon@brc.aphp.fr   
Principal Investigator: Olivier HANON, MD PhD         
Sub-Investigator: Clémence BOULLY, MD         
Sub-Investigator: Edouard CHAUSSADE, MD         
Sub-Investigator: Sophie CHAUVELIER, MD         
Sub-Investigator: Florian LABOUREE, MD         
Sub-Investigator: Laure CAILLARD, MD         
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69310
Contact: Claire GRANGE, MD    04.78.86.14.63 ext +33    claire.grange@chu-lyon.fr   
Principal Investigator: Claire GRANGE, MD         
Sub-Investigator: Jean Christophe LEGA, MD         
CHU de Rouen Not yet recruiting
Rouen, France, 76000
Contact: Ygal BENHAMOU, MD         
Principal Investigator: Ygal BENHAMOU, MD         
CHU de Saint Etienne Recruiting
Saint Etienne Cedex, France, 42055
Contact: Patrick MISMETTI, MD PhD    0477120285 ext +33    patrick.mismetti@chu-st-etienne.fr   
Principal Investigator: Patrick MISMETTI, MD PhD         
Sub-Investigator: Laurent BERTOLETTI, MD PhD         
Sub-Investigator: Nathalie MOULIN, MD         
Sub-Investigator: Sandrine ACCASSAT, MD         
Sub-Investigator: Andréa BUCHMULLER, MD         
Sub-Investigator: Elodie DE MAGALHAES, MD         
Sub-Investigator: Cécile DUVILLARD, MD         
Sub-Investigator: Eric DICONNE, MD         
Sub-Investigator: Pierre LAFOND, MD         
Sub-Investigator: Bernard TARDY, MD PhD         
CHU de Strasbourg - Hôpital Civil Recruiting
Strasbourg, France, 67000
Contact: Dominique STEPHAN, MD PhD         
Principal Investigator: Dominique STEPHAN, MD PhD         
Sub-Investigator: Alix-Marie FALLER, MD         
Sub-Investigator: Elena-Mihaela CORDEANU, MD         
Sub-Investigator: Sébastien GAERTNER, MD         
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer Not yet recruiting
Toulon, France, 83056
Contact: Antoine ELIAS, MD    04 94 14 52 35 ext +33    antoine.elias@free.fr   
Principal Investigator: Antoine ELIAS, MD         
Sub-Investigator: Marie ELIAS, MD         
Sub-Investigator: Colin RICHARD, MD         
Sub-Investigator: Anaïs CORNE, MD         
Sub-Investigator: Dimitri CORNAND, MD         
CHU Tours Recruiting
Tours, France, 37000
Contact: Denis ANGOULVANT, MD PhD         
Principal Investigator: Denis ANGOULVANT, MD PhD         
Sub-Investigator: Fabrice IVANES, MD         
Sub-Investigator: Thibaud GENET, MD         
Sub-Investigator: Christophe SAINT-ETIENNE, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Patrick MISMETTI, MD PhD CHU de Saint Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02360943     History of Changes
Other Study ID Numbers: 1208182
2013-000315-24 ( EudraCT Number )
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
elderly patients
Pulmonary embolism
Anticoagulant treatments

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Anticoagulants