MedDataX Logo

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

NCT ID: NCT00457158

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Embolism Venous Thrombosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

pulmonary embolism inferior vena cava filters venous thrombosis randomized controlled trial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

ALN optional filter

Group Type EXPERIMENTAL

ALN optional filter

Intervention Type DEVICE

J1 : ALN optional filter M3 : ALN optional filter removed

2

No ALN optional filter

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ALN optional filter

J1 : ALN optional filter M3 : ALN optional filter removed

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Fondation de France

OTHER

Sponsor Role collaborator

Fondation de l'Avenir

OTHER

Sponsor Role collaborator

ALN Implants Company

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Patrick MISMETTI, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service de Médecine Vasculaire, CHU Amiens

Amiens, , France

Site Status

Service d'Accueil des Urgences, CHU d'Angers

Angers, , France

Site Status

Service de Cardiologie, CHU de Besançon

Besançon, , France

Site Status

CHU de Bordeaux

Bordeaux, , France

Site Status

Département de Medecine Interne et Pneumologie, CHU de Brest

Brest, , France

Site Status

Service de Pneumologie, Hôpital Antoine Beclere

Clamart, , France

Site Status

Service d'Accueil des Urgences, CHU de Clermont Ferrand

Clermont-Ferrand, , France

Site Status

CHU de Dijon

Dijon, , France

Site Status

Service des Urgences, CHG de Firminy

Firminy, , France

Site Status

Unité de Médecine Vasculaire, CHU de Grenoble

Grenoble, , France

Site Status

Service d'Urgences Soins Intensifs cardiologiques, CHU de Lille

Lille, , France

Site Status

Hôpital Edouard Herriot

Lyon, , France

Site Status

Service de Medecine Interne et Maladies Vasculaires, CHU de Montpellier

Montpellier, , France

Site Status

Service de Medecine Interne et Vasculaire, CHU de Nancy

Nancy, , France

Site Status

Service de Cardiologie, CHU de Nice

Nice, , France

Site Status

Département de Pneumologie, Hôpital Européen Georges Pompidou, AP HP

Paris, , France

Site Status

Service d'Urgences et de Réanimation Medicale, CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Service de Medecine et Therapeutique - CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Service de Médecine Vasculaire, CH Toulon

Toulon, , France

Site Status

Service de Cardiologie, CHU de Tours

Tours, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 9459643 (View on PubMed)

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. doi: 10.1161/CIRCULATIONAHA.104.512834. Epub 2005 Jul 11.

Reference Type BACKGROUND
PMID: 16009794 (View on PubMed)

Mismetti 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.

Reference Type DERIVED
PMID: 25919526 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2006-01-001

Identifier Type: -

Identifier Source: secondary_id

0501105

Identifier Type: -

Identifier Source: org_study_id