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

Study Description

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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 Design

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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 2018
Estimated Study Completion Date :	June 2019

Groups and Cohorts

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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

Outcome Measures

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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 ]

Eligibility Criteria

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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

Contacts and Locations

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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
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
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
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
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
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

More Information

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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Last Update Posted:	October 23, 2017
Last Verified:	October 2017
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