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

August 24, 2022 updated by: Centre Hospitalier Universitaire de Saint Etienne

Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: Prospective, Multicenter Cohort Study PEAGE

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • CHU d'Angers
      • Besancon, France, 25000
        • Hôpital Universitaire Jean Minjoz
      • Brest, France, 29609
        • CHU de Brest
      • Castelnau Le Lez, France, 34170
        • Clinique du Parc - Castelnau Le Lez
      • Clermont Ferrand, France, 63003
        • Chu Gabriel Montpied
      • Colombes, France, 92700
        • Hôpitaux Universitaires Louis Mourier Paris Nord
      • Dijon, France, 21079
        • CHU de Dijon
      • Grenoble, France, 38043
        • CHU de GRENOBLE
      • Limoges, France, 87000
        • CHU de Limoges
      • Montpellier, France, 34295
        • CHU de Montpellier
      • Nantes, France, 44093
        • CHRU de Nantes
      • Nice, France, 06002
        • Chu De Nice
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou, APHP
      • Paris, France
        • APHP Hôpital Broca
      • Pierre Benite, France, 69310
        • Centre Hospitalier LYON SUD
      • Rouen, France, 76000
        • CHU de Rouen
      • Saint Etienne Cedex, France, 42055
        • CHU de Saint Etienne
      • Strasbourg, France, 67000
        • CHU de Strasbourg - Hôpital Civil
      • Toulon, France, 83056
        • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
      • Tours, France, 37000
        • CHU Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 6 months
Recurrent pulmonary embolism
Time Frame: at 6 months
confirmed by CT scan or ventilation/perfusion lung scan
at 6 months
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
at 6 months
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.
at 6 months
Death
Time Frame: at 6 months
at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Patrick MISMETTI, MD PhD, CHU de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 9, 2014

Primary Completion (ACTUAL)

October 15, 2021

Study Completion (ACTUAL)

April 22, 2022

Study Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (ESTIMATE)

February 11, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1208182
  • 2013-000315-24 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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