Status:
COMPLETED
PREPIC 2 : Prevention of Recurrent Pulmonary Embolism by Vena Cava Interruption
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Ministry of Health, France
Fondation de France
Conditions:
Pulmonary Embolism
Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess efficacy and safety of optional vena cava filter implanted 3 months in prevention of recurrent pulmonary embolism in patients presenting with acute pulmonary emb...
Detailed Description
Pulmonary embolism is a common pathology, which could be fatal (about 10 000 death/year in France). It mainly originates from a deep vein thrombosis. In order to reduce mortality, prevention of new or...
Eligibility Criteria
Inclusion
- Informed consent
- Acute symptomatic pulmonary embolism; AND
- Deep or superficial vein thrombosis; AND
- At least one of the risk factors below :
- More than 75 years old
- Evolutiv cancer (excepting locally cutaneous cancer)
- Known chronic heart failure treated
- Chronic respiratory insufficiency treated
- Bilateral deep vein thrombosis
- Ilio-cava thrombosis
- Ischemic stroke \> 3 days and \< 6 months, with lower limb deficit
- Cardiac repercussion of pulmonary embolism assessed by echocardiography or increasing troponin I or T, or Brain Natriuretic Peptid or proBNP
Exclusion
- Contrindication to an anticoagulant treatment or recurrent thromboembolic event despite adequate anticoagulation
- Vena cava filter already inserted
- Filter insertion impossible due to caval thrombosis
- More than 72 hours pre-randomized treatment with therapeutic dosage of anticoagulant therapy
- Non carcinologic surgery within 3 months prior randomization
- Carcinologic surgery within 10 days prior randomization
- Hypersensitivity to contrast media
- Access port in place or programmed within 3 months
- Woman who are child bearing
- Life expectancy \< 6 months
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT00457158
Start Date
July 1 2006
End Date
November 1 2012
Last Update
November 27 2012
Active Locations (20)
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1
Service de Médecine Vasculaire, CHU Amiens
Amiens, France, 80080
2
Service d'Accueil des Urgences, CHU d'Angers
Angers, France, 49100
3
Service de Cardiologie, CHU de Besançon
Besançon, France, 25000
4
CHU de Bordeaux
Bordeaux, France, 33000