PREPIC 2 : Prevention of Recurrent Pulmonary Embolism by Vena Cava Interruption (PREPIC2)

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, France
Fondation de France
Fondation de l'Avenir
ALN Implants Company
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00457158
First received: April 4, 2007
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Pulmonary Embolism
Venous Thrombosis
Device: ALN optional filter
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • 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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • current or new symptomatic DVT confirmed by objective tests [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • mecanical complication of filter (migration, tilt, transfixion) and or puncture site hematoma, and/or local or general infection due to filter [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • filter thrombosis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • filter retrieval failure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • total death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 399
Study Start Date: July 2006
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ALN optional filter
Device: ALN optional filter
J1 : ALN optional filter M3 : ALN optional filter removed
No Intervention: 2
No ALN optional filter

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457158

Locations
France
Service de Médecine Vasculaire, CHU Amiens
Amiens, France, 80080
Service d'Accueil des Urgences, CHU d'Angers
Angers, France, 49100
Service de Cardiologie, CHU de Besançon
Besançon, France, 25000
CHU de Bordeaux
Bordeaux, France, 33000
Département de Medecine Interne et Pneumologie, CHU de Brest
Brest, France, 29200
Service de Pneumologie, Hôpital Antoine Beclere
Clamart, France, 92140
Service d'Accueil des Urgences, CHU de Clermont Ferrand
Clermont Ferrand, France, 63000
CHU de Dijon
Dijon, France, 21000
Service des Urgences, CHG de Firminy
Firminy, France, 42700
Unité de Médecine Vasculaire, CHU de Grenoble
Grenoble, France, 38000
Service d'Urgences Soins Intensifs cardiologiques, CHU de Lille
Lille, France, 59000
Hôpital Edouard Herriot
Lyon, France, 69437
Service de Medecine Interne et Maladies Vasculaires, CHU de Montpellier
Montpellier, France, 34295
Service de Medecine Interne et Vasculaire, CHU de Nancy
Nancy, France, 54000
Service de Cardiologie, CHU de Nice
Nice, France, 06000
Département de Pneumologie, Hôpital Européen Georges Pompidou, AP HP
Paris, France, 75015
Service d'Urgences et de Réanimation Medicale, CHU de Saint-Etienne
Saint-Etienne, France, 42055
Service de Medecine et Therapeutique - CHU de Saint-Etienne
Saint-Etienne, France, 42055
Service de Médecine Vasculaire, CH Toulon
Toulon, France, 83056
Service de Cardiologie, CHU de Tours
Tours, France, 37000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Fondation de France
Fondation de l'Avenir
ALN Implants Company
Investigators
Principal Investigator: Patrick MISMETTI, MD PhD CHU de Saint-Etienne
  More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00457158     History of Changes
Other Study ID Numbers: 0501105, 2006-01-001
Study First Received: April 4, 2007
Last Updated: November 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
pulmonary embolism
inferior vena cava filters
venous thrombosis
randomized controlled trial

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Thromboembolism
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014