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

  • STATUS
    Recruiting
  • End date
    Jun 18, 2022
  • participants needed
    1500
  • sponsor
    Centre Hospitalier Universitaire de Saint Etienne
Updated on 18 April 2021
Investigator
Patrick MISMETTI, MD PhD
Primary Contact
CHU Gabriel Montpied (0.0 mi away) Contact
+24 other location
anticoagulants
vitamin k antagonist
vitamin k
thromboembolism
fondaparinux
venous thromboembolic disease

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.

Details
Condition Pulmonary Disease, Anticoagulants, Pulmonary Embolism, Aged, Lung Disease, anticoagulant, blood thinner, agents, anticoagulant, anticoagulation agents, blood thinners, anticoagulant drugs, lung embolism
Treatment 4 blood samples
Clinical Study IdentifierNCT02360943
SponsorCentre Hospitalier Universitaire de Saint Etienne
Last Modified on18 April 2021

Eligibility

Yes No Not Sure

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
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