RECOVERY DVTPE Tt & Secondary Prevention/Acute Venous Thromboembolism
Research type
Research Study
Full title
ChaRactErization of patients following aCute venous thrOmboembolism (VTE) and assessment of safety and effectiveness of dabigatran etexilate (DE) in the tReatment and secondarY prevention of acute deep vein thrombosis (DVT) and pulmonary embolism (PE) in comparison to vitamin K antagonist (VKA) in routine clinical practice - RE-COVERY DVT/PE
IRAS ID
199239
Contact name
Dimitrios Paximadas
Contact email
Sponsor organisation
Boehringer Ingelheim (Canada) Ltd./Ltée
Clinicaltrials.gov Identifier
219200, PAREXEL
Duration of Study in the UK
2 years, 1 months, 17 days
Research summary
Venous Thromboembolism (VTE) includes 2 related events: Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE). The venous thrombus usually develops in the deep veins of the leg or pelvis. Thrombus from a DVT can propagate and/or embolize to the pulmonary circulation, resulting in a PE, which can turn into an acute life-threatening condition.
Anticoagulant therapy is the standard treatment for venous blood clots, preventing new blood clots from forming, and preventing existing blood clots from getting larger and leading to dissolution of the existing clot after successful treatment. Rapid anticoagulation will minimize the risk of thrombus extension and PE in patients with VTE. Anticoagulation treatment should last at least 3 months. Longer treatment may be recommended depending on the nature of the initial event.
Non-vitamin K Anticoagulant (NOAC)therapy including Factor Xa inhibitors (e.g., apixaban, rivaroxaban or edoxaban) and direct thrombin inhibitors (e.g., Dabigatran Etexilate (DE)) have been used recently for prevention and treatment of VTE. These agents have fewer drug-drug or dietary interactions and do not require rigorous International Normalized Ratio (INR) monitoring compared with Vitamin K Antagonists (VKAs).
The efficacy and safety of dabigatran etexilate versus warfarin has been tested in 4 pivotal, randomized, double-blind, clinical trials. A dose of 150 mg b.i.d. of dabigatran etexilate was tested in all 4 trials. The safety profile of dabigatran etexilate from these studies is consistent with the available safety data from other indications. The most common related adverse events (AE) for dabigatran etexilate included bleeding and gastrointestinal adverse events; however, dabigatran etexilate had fewer major or clinically relevant bleeding events compared to warfarin.
The RE-COVERY DVT/PE study will attempt to characterize the DVT / PE patient population and to analyze the safety and effectiveness of dabigatran etexilate regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0343
Date of REC Opinion
2 Sep 2016
REC opinion
Further Information Favourable Opinion