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

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ClinicalTrials.gov Identifier: NCT02360943
Recruitment Status : Recruiting
First Posted : February 11, 2015
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Elderly Pulmonary Embolism Anticoagulants Other: 4 blood samples

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: Prospective, Multicenter Cohort Study PEAGE
Actual Study Start Date : July 9, 2014
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PEAGE
Patients older than 75 years receiving an anticoagulant treatment for a symptomatic and confirmed PE
Other: 4 blood samples
PK and / or PD measurements during hospitalization




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients older than 75 years receiving an anticoagulant treatment (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants) for a symptomatic and confirmed pulmonary embolism
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360943


Contacts
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Contact: Patrick MISMETTI, MD PhD 0477120285 ext +33 patrick.mismetti@chu-st-etienne.fr

Locations
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Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
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Principal Investigator: Patrick MISMETTI, MD PhD CHU de Saint Etienne
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02360943    
Other Study ID Numbers: 1208182
2013-000315-24 ( EudraCT Number )
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
elderly patients
Pulmonary embolism
Anticoagulant treatments
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases