Boehringer Ingelheim has enrolled the first patient in a global observational study on the management of blood clots in the legs (deep vein thrombosis, DVT) and in the lungs (pulmonary embolism, PE).
The aim of the RE-COVERY DVT/PE study is to provide insight into how patients with these conditions are managed in real-world clinical practice, adding to the body of data on the safety and effectiveness of its bloodthinner Pradaxa (dabigatran etexilate) compared to warfarin.
“Large pivotal randomised trials have revolutionised our strategies to manage and reduce the risk of DVT and PE. However, it remains uncertain how the results of these trials impact everyday clinical practice in the ‘real world’”, said Samuel Goldhaber, Professor of Medicine at Harvard Medical School and Chair of trial’s steering committee, explaining the premise for the research.
Pradaxa, a direct thrombin inhibitor, is cleared for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.
The drug is also the only novel oral anticoagulant with an approved reversal agent; Praxbind (idarucizumab) is indicated for use in adult patients treated with Pradaxa who require rapid reversal of its anticoagulant effects prior to urgent procedures/emergency surgery or in life threatening or uncontrolled bleeding.