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 : April 13, 2021
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|
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|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|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||June 2022|
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
- 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
- Clinically relevant non-major bleeding [ Time Frame: at 6 months ]
- 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 [ Time Frame: at 6 months ]confirmed by CT scan or ventilation/perfusion lung scan
- 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
- 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.
- Death [ Time Frame: at 6 months ]
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
|Contact: Patrick MISMETTI, MD PhD||0477120285 ext +email@example.com|
|Principal Investigator:||Patrick MISMETTI, MD PhD||CHU de Saint Etienne|