PREPIC 2 2009.

Trial name or title	PREPIC 2 : Interruption of inferior vena cava by a retrievable filter for the prevention of recurrent pulmonary embolism : a randomised, open label study.
Methods	Study design: Randomized, open label, active control, parallel assignment, safety/efficacy study.
Participants	Age: > 18 years. 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. 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 Peptide (BNP) 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‐randomised treatment with therapeutic dosage of anticoagulant therapy. Non carcinologic surgery within three months prior randomisation. Carcinologic surgery within 10 days prior randomisation. Hypersensitivity to contrast media. Access port in place or programmed within 3 months. Woman who are child bearing. Life expectancy < 6 months
Interventions	Treatment: optional/retrievable filter. Control: No filter.
Outcomes	Primary outcomes: at three months, combined criteria including recurrent PE confirmed by objective tests and fatal PE confirmed by autopsy and death which cannot be attributed to a documented cause and for which PE/DVT cannot be ruled out. Secondary outcomes: Recurrent pulmonary embolism, fatal or not, at six months (combined criteria including recurrent pulmonary embolism confirmed by objective tests and fatal PE confirmed by autopsy and death which cannot be attributed to a documented cause). Current or new symptomatic DVT confirmed by objective tests. Mechanical complication of filter (migration, tilt, transfixion) and or puncture site hematoma, and/or local or general infection due to filter. Filter thrombosis. Filter retrieval failure. Total death.
Starting date	July 2006
Contact information	Patrick Mismetti, MD PhD, Karine Rivron Guillot, MD
Notes	NCT00457158