Pharmaco-epidemiology of the treatment of the symptomatic pulmonary embolism among in-patients and 75 years old or more: prospective, multicentric PEAGE cohort

Phase 1

• Conditions: Symptomatic pulmunory embolism on patients over 75 years; MedDRA version: 20.0 Level: HLT Classification code 10037379 Term: Pulmonary embolism and thrombosis System Organ Class: 100000004866; MedDRA version: 20.0 Level: PT Classification code 10037377 Term: Pulmonary embolism System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-000315-24-FR
• Lead Sponsor: CHU SAINT-ETIENNE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-16
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1500

Inclusion Criteria

- Age > or = to 75 years
- Symptomatic pulmonary embolism confirmed by objective paraclinical
examination (CT or scintigraphy) with or without DVT associated
- Date of PE within 3 days
- Administration possible according to the recommended dosages of
anticoagulation whatever it is: UFH, LMWH (dalteparin, enoxaparin,
Fraxiparin, tinzaparin), fondaparinux, oral anticoagulants
(acenocoumarol, fluindione, warfarin) or oral anticoagulants direct according to AMM
(apixaban, dabigatran, edoxaban , rivaroxaban)
- Indication of anticoagulant therapy for a period of at least 6 months
- Prognosis vital compatible with 6 month follow up
- Written informed consent obtained
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1500

Exclusion Criteria

- prescribed anticoagulant treatment on therapeutic dose over 72 hours
- indication of a therapeutic dose anticoagulant treatment for another
reason.
- Inability for whatever reasons, to prescribe at least one recommended
anticoagulant treatment to VTE-PE treatment on heparin-induced
thrombocytopenia requiring argatroban, lepirudin or danaparoid
treatment,
- bleeding
- PE occurring despite well conducted anticoagulant treatment
- Contraindications to recommended dose anticoagulant treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified