PREPIC 2 : Prevention of Recurrent Pulmonary Embolism by Vena Cava Interruption
PREPIC2
PREPIC 2 : Interruption of Inferior Vena Cava by a Retrievable Filter for the Prevention of Recurrent Pulmonary Embolism : a Randomised, Open Label Study
2 other identifiers
interventional
399
1 country
20
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 embolism associated with thrombotic risk factors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2006
Longer than P75 for phase_4
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 4, 2007
CompletedFirst Posted
Study publicly available on registry
April 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedNovember 27, 2012
November 1, 2012
6.3 years
April 4, 2007
November 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
at 3 months, combined criteria including recurrent PE confirmed by objective tests and fatal PE confirmed by autopsy and death which can not be attribuated to a documented cause and for which PE/DVT can't be ruled out
3 months
Secondary Outcomes (6)
recurrent pulmonary embolism, fatal or not, at 6 months (combined criteria including recurrent pulmonary ambolism confirmed by objective tests and fatal PE confirmed by autopsy and death which can not be attribuated to a documented cause and for which P
6 months
current or new symptomatic DVT confirmed by objective tests
6 months
mecanical complication of filter (migration, tilt, transfixion) and or puncture site hematoma, and/or local or general infection due to filter
6 months
filter thrombosis
6 months
filter retrieval failure
6 months
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALALN optional filter
2
NO INTERVENTIONNo ALN optional filter
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire de Saint Etiennelead
- Ministry of Health, Francecollaborator
- Fondation de Francecollaborator
- Fondation de l'Avenircollaborator
- ALN Implants Companycollaborator
Study Sites (20)
Service de Médecine Vasculaire, CHU Amiens
Amiens, 80080, France
Service d'Accueil des Urgences, CHU d'Angers
Angers, 49100, France
Service de Cardiologie, CHU de Besançon
Besançon, 25000, France
CHU de Bordeaux
Bordeaux, 33000, France
Département de Medecine Interne et Pneumologie, CHU de Brest
Brest, 29200, France
Service de Pneumologie, Hôpital Antoine Beclere
Clamart, 92140, France
Service d'Accueil des Urgences, CHU de Clermont Ferrand
Clermont-Ferrand, 63000, France
CHU de Dijon
Dijon, 21000, France
Service des Urgences, CHG de Firminy
Firminy, 42700, France
Unité de Médecine Vasculaire, CHU de Grenoble
Grenoble, 38000, France
Service d'Urgences Soins Intensifs cardiologiques, CHU de Lille
Lille, 59000, France
Hôpital Edouard Herriot
Lyon, 69437, France
Service de Medecine Interne et Maladies Vasculaires, CHU de Montpellier
Montpellier, 34295, France
Service de Medecine Interne et Vasculaire, CHU de Nancy
Nancy, 54000, France
Service de Cardiologie, CHU de Nice
Nice, 06000, France
Département de Pneumologie, Hôpital Européen Georges Pompidou, AP HP
Paris, 75015, France
Service d'Urgences et de Réanimation Medicale, CHU de Saint-Etienne
Saint-Etienne, 42055, France
Service de Medecine et Therapeutique - CHU de Saint-Etienne
Saint-Etienne, 42055, France
Service de Médecine Vasculaire, CH Toulon
Toulon, 83056, France
Service de Cardiologie, CHU de Tours
Tours, 37000, France
Related Publications (3)
Decousus H, Leizorovicz A, Parent F, Page Y, Tardy B, Girard P, Laporte S, Faivre R, Charbonnier B, Barral FG, Huet Y, Simonneau G. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. Prevention du Risque d'Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998 Feb 12;338(7):409-15. doi: 10.1056/NEJM199802123380701.
PMID: 9459643BACKGROUNDPREPIC Study Group. Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC (Prevention du Risque d'Embolie Pulmonaire par Interruption Cave) randomized study. Circulation. 2005 Jul 19;112(3):416-22. doi: 10.1161/CIRCULATIONAHA.104.512834. Epub 2005 Jul 11.
PMID: 16009794BACKGROUNDMismetti P, Laporte S, Pellerin O, Ennezat PV, Couturaud F, Elias A, Falvo N, Meneveau N, Quere I, Roy PM, Sanchez O, Schmidt J, Seinturier C, Sevestre MA, Beregi JP, Tardy B, Lacroix P, Presles E, Leizorovicz A, Decousus H, Barral FG, Meyer G; PREPIC2 Study Group. Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism: a randomized clinical trial. JAMA. 2015 Apr 28;313(16):1627-35. doi: 10.1001/jama.2015.3780.
PMID: 25919526DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick MISMETTI, MD PhD
CHU de Saint-Etienne
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2007
First Posted
April 5, 2007
Study Start
July 1, 2006
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
November 27, 2012
Record last verified: 2012-11