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

• ClinicalTrials.gov Identifier: NCT02360943
• Recruitment Status: Recruiting
• First Posted: February 11, 2015
• Last Update Posted: January 27, 2020
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborator: Ministry of Health, France
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Saint Etienne

Study Description

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

• 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
• Actual Primary Completion Date: December 31, 2019
• Estimated Study Completion Date: June 2020

Groups and Cohorts

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

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

• 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

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; 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; 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; 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; 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; 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; 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

More Information

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT02360943
• Other Study ID Numbers: 1208182; 2013-000315-24 ( EudraCT Number )
• First Posted: February 11, 2015
• Last Update Posted: January 27, 2020
• Last Verified: January 2020

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:

Pulmonary Embolism; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases