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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Pulmonary Embolism; Anticoagulants; Elderly

Treatments: Other: 4 blood samples

Study type: Observational

Funder types: Other

Identifiers

NCT02360943

1208182

2013-000315-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,500 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,500 participants in 1 patient group

PEAGE

Description:

Patients older than 75 years receiving an anticoagulant treatment for a symptomatic and confirmed PE

Treatment:

Other: 4 blood samples