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

Pulmonary Embolism Clinical Trial

— PEAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360943
• Other study ID #: 1208182
• Secondary ID: 2013-000315-24
• Status: Completed
• Start date: July 9, 2014
• Est. completion date: April 22, 2022

Study information

• Verified date: August 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: April 22, 2022
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulants
• Elderly
• Embolism
• Pulmonary Embolism

Intervention

Other:
• 4 blood samples
PK and / or PD measurements during hospitalization

Locations

Country	Name	City	State
France	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	CHRU de Nantes	Nantes
France	CHU de Nice	Nice
France	APHP Hôpital BROCA	Paris
France	Hôpital Europeen Georges Pompidou, APHP	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	CHU de Rouen	Rouen
France	CHU de Saint Etienne	Saint Etienne Cedex
France	CHU de Strasbourg - Hôpital Civil	Strasbourg
France	Centre Hospitalier Intercommunal Toulon La Seyne sur Mer	Toulon
France	CHU Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major bleeding defined by the International Society of Thrombosis & Haemostasis	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	Clinically relevant non-major bleeding	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
Secondary	Recurrent pulmonary embolism	confirmed by CT scan or ventilation/perfusion lung scan	at 6 months
Secondary	Deep vein thrombosis (recurrence or new)	confirmed by venous doppler ultrasonography or venography of the lower limbs or CT scan	at 6 months
Secondary	Arterial cardiovascular events	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
Secondary	Death		at 6 months