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Pulmonary EmbolismPhase 4PREPIC2NCT00457158

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

A Phase 4 study testing ALN optional filter in people with Pulmonary Embolism and Venous Thrombosis, run by Centre Hospitalier Universitaire de Saint Etienne at 20 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism, Venous Thrombosis
What is being tested?
ALN optional filter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
399 participants
Where
20 sitesFrance
Study dates
Jul 2006to Nov 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Hypersensitivity to contrast media
  • Access port in place or programmed within 3 months
  • Woman who are child bearing
  • Life expectancy < 6 months

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • Service de Médecine Vasculaire, CHU Amiens

    Amiens, 80080

  • Service d'Accueil des Urgences, CHU d'Angers

    Angers, 49100

  • Service de Cardiologie, CHU de Besançon

    Besançon, 25000

  • CHU de Bordeaux

    Bordeaux, 33000

  • Département de Medecine Interne et Pneumologie, CHU de Brest

    Brest, 29200

  • Service de Pneumologie, Hôpital Antoine Beclere

    Clamart, 92140

  • Service d'Accueil des Urgences, CHU de Clermont Ferrand

    Clermont-Ferrand, 63000

  • CHU de Dijon

    Dijon, 21000

  • Service des Urgences, CHG de Firminy

    Firminy, 42700

  • Unité de Médecine Vasculaire, CHU de Grenoble

    Grenoble, 38000

  • Service d'Urgences Soins Intensifs cardiologiques, CHU de Lille

    Lille, 59000

  • Hôpital Edouard Herriot

    Lyon, 69437

  • Service de Medecine Interne et Maladies Vasculaires, CHU de Montpellier

    Montpellier, 34295

  • Service de Medecine Interne et Vasculaire, CHU de Nancy

    Nancy, 54000

  • Service de Cardiologie, CHU de Nice

    Nice, 06000

  • Département de Pneumologie, Hôpital Européen Georges Pompidou, AP HP

    Paris, 75015

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

    Saint-Etienne, 42055

  • Service de Medecine et Therapeutique - CHU de Saint-Etienne

    Saint-Etienne, 42055

  • Service de Médecine Vasculaire, CH Toulon

    Toulon, 83056

  • Service de Cardiologie, CHU de Tours

    Tours, 37000

Other trials in France

About this study

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

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

Read the 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.

Being tested
ALN optional filter
Keywords
pulmonary embolism, inferior vena cava filters, venous thrombosis, randomized controlled trial
Medical subject headings
Pulmonary Embolism, Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALN optional filterDevice

    J1 : ALN optional filter M3 : ALN optional filter removed

Study groups in NCT00457158
Study groupRoleWhat they receive
1ExperimentalALN optional filter
Receives: Device: ALN optional filter
2No interventionNo ALN optional filter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months

Secondary outcomes (6)

  1. 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

    Measured: 6 months

  2. current or new symptomatic DVT confirmed by objective tests

    Measured: 6 months

  3. mecanical complication of filter (migration, tilt, transfixion) and or puncture site hematoma, and/or local or general infection due to filter

    Measured: 6 months

  4. filter thrombosis

    Measured: 6 months

  5. filter retrieval failure

    Measured: 6 months

  6. total death

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2007 (estimated)
  2. Study startJul 2006
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00457158
Sponsor's protocol ID
0501105
Other IDs
2006-01-001
Acronym
PREPIC2
Status last verified
Nov 2012
First submitted
4 Apr 2007
Last updated
27 Nov 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 9459643

  • 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.

    PubMed 16009794

  • 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.

    PubMed 25919526

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ALN optional filter in people with Pulmonary Embolism and Venous Thrombosis, run by Centre Hospitalier Universitaire de Saint Etienne at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00457158, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012; AzTrials last refreshed its copy on 8 Nov 2026.

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