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

Completed

• Conditions: Elderly; Pulmonary Embolism; Anticoagulants

• Registration Number: NCT02360943
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-09
• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-11
• Primary Completion: 2021-10-15
• Study Completion: 2022-04-22
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major bleeding defined by the International Society of Thrombosis & Haemostasis	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

Name	Time	Method
Clinically relevant non-major bleeding	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
Recurrent pulmonary embolism	at 6 months	confirmed by CT scan or ventilation/perfusion lung scan
Deep vein thrombosis (recurrence or new)	at 6 months	confirmed by venous doppler ultrasonography or venography of the lower limbs or CT scan
Arterial cardiovascular events	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.
Death	at 6 months

Trial Locations

Locations (20)

CHU d'Angers; 🇫🇷 Angers, France

Hôpital Universitaire Jean Minjoz; 🇫🇷 Besancon, France

CHU de Brest; 🇫🇷 Brest, France

Clinique du Parc - Castelnau Le Lez; 🇫🇷 Castelnau Le Lez, France

CHU Gabriel Montpied; 🇫🇷 Clermont Ferrand, France

Hôpitaux Universitaires Louis Mourier Paris Nord; 🇫🇷 Colombes, France

CHU de Dijon; 🇫🇷 Dijon, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU de Limoges; 🇫🇷 Limoges, France

CHU de Montpellier; 🇫🇷 Montpellier, France

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