PREPIC 2 : Prevention of Recurrent Pulmonary Embolism by Vena Cava

Status Completed

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

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00457158
Study type	Interventional
Source	Centre Hospitalier Universitaire de Saint Etienne
Contact
Status	Completed
Phase	Phase 4
Start date	July 2006
Completion date	November 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms