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NCT Number: NCT02360943

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

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Key information

Conditions

Elderly Anticoagulants Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4 blood samples

Other

PK and / or PD measurements during hospitalization

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Recurrent pulmonary embolism

    Time frame: at 6 months

    confirmed by CT scan or ventilation/perfusion lung scan

  3. 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

  4. 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.

  5. Death

    Time frame: at 6 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: PEAGE

Important dates

Study start
2014
Primary completion
2021
Study completion
2022
First posted
Feb 11, 2015
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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