PREPIC 2 : Prevention of Recurrent Pulmonary Embolism by Vena Cava Interruption

Pulmonary Embolism Clinical Trial

— PREPIC2  

Official title:

PREPIC 2 : Interruption of Inferior Vena Cava by a Retrievable Filter for the Prevention of Recurrent Pulmonary Embolism : a Randomised, Open Label Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457158
• Other study ID #: 0501105
• Secondary ID: 2006-01-001
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2007
• Last updated: November 22, 2012
• Start date: July 2006
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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

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 recurrent PE is a major therapeutic aim. Only one randomised trial (PREPIC) assessed the interest of a vena cava filter in patients treated by anticoagulant treatment for a deep vein thrombosis (DVT). Results show a significant 50 % reduction of the embolic risk with the filter. This benefit occurs from the first days, but are counterbalanced by a long-term increasing risk of recurrent DVT. The filter appears promising in patients with a high risk of PE, for exemple the elderly, presenting with a thromboembolic history, cancer, heart failure or respiratory insufficiency, or a recent PE. Moreover, retrievable filters, which may be either left in place permanently or retrieved after some days or weeks, could limit the filter thrombosis risk.

The aim of PREPIC 2 study is to assess, in a multicenter randomised trial, efficacy and safety of a retrievable vena cava filter implanted 3 months versus no filter in 400 patients treated with anticoagulant drugs for a symptomatic PE associated with at least one thrombotic risk factor. A clinical follow-up will be performed at 6 months. The primary outcome is the incidence of recurrent PE at 3 months, including symptomatic and fatal PE. It will be adjudicated by an independent committee, blinded to patients' allocation.

This study will assess the benefit risk ratio of the retrievable filter for the prevention of recurrent PE, without increasing the thrombotic risk and the disadvantage due to post thrombotic syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• ALN optional filter
J1 : ALN optional filter M3 : ALN optional filter removed

Locations

Country	Name	City	State
France	Service de Médecine Vasculaire, CHU Amiens	Amiens
France	Service d'Accueil des Urgences, CHU d'Angers	Angers
France	Service de Cardiologie, CHU de Besançon	Besançon
France	CHU de Bordeaux	Bordeaux
France	Département de Medecine Interne et Pneumologie, CHU de Brest	Brest
France	Service de Pneumologie, Hôpital Antoine Beclere	Clamart
France	Service d'Accueil des Urgences, CHU de Clermont Ferrand	Clermont Ferrand
France	CHU de Dijon	Dijon
France	Service des Urgences, CHG de Firminy	Firminy
France	Unité de Médecine Vasculaire, CHU de Grenoble	Grenoble
France	Service d'Urgences Soins Intensifs cardiologiques, CHU de Lille	Lille
France	Hôpital Edouard Herriot	Lyon
France	Service de Medecine Interne et Maladies Vasculaires, CHU de Montpellier	Montpellier
France	Service de Medecine Interne et Vasculaire, CHU de Nancy	Nancy
France	Service de Cardiologie, CHU de Nice	Nice
France	Département de Pneumologie, Hôpital Européen Georges Pompidou, AP HP	Paris
France	Service d'Urgences et de Réanimation Medicale, CHU de Saint-Etienne	Saint-Etienne
France	Service de Medecine et Therapeutique - CHU de Saint-Etienne	Saint-Etienne
France	Service de Médecine Vasculaire, CH Toulon	Toulon
France	Service de Cardiologie, CHU de Tours	Tours

Sponsors (5)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	ALN Implants Company, Fondation de France, Fondation de l'Avenir, Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (2)

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. Prévention du Risque d'Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998 Feb 12;338(7):409-15. — View Citation

PREPIC 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. Epub 2005 Jul 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	current or new symptomatic DVT confirmed by objective tests		6 months	No
Secondary	mecanical complication of filter (migration, tilt, transfixion) and or puncture site hematoma, and/or local or general infection due to filter		6 months	Yes
Secondary	filter thrombosis		6 months	Yes
Secondary	filter retrieval failure		6 months	Yes
Secondary	total death		6 months	Yes