The Caravaggio Study
Research type
Research Study
Full title
APIXABAN FOR THE TREATMENT OF VENOUS THROMBOEMBOLISM IN PATIENTS WITH CANCER: A PROSPECTIVE RANDOMIZED OPEN BLINDED END-POINT (PROBE) STUDY - THE CARAVAGGIO STUDY
IRAS ID
222840
Contact name
Raza Alikhan
Contact email
Eudract number
2016-003093-40
Duration of Study in the UK
2 years, 1 months, 5 days
Research summary
Venous thromboembolism (VTE) is a common clinical event in patients with cancer. The development of VTE is presumed to be due to the production of pro-coagulant molecules by cancer cells and to the pro-coagulant effect of cancer cells spread into the circulation. It should be taken into account that cancer surgery and chemotherapy are associated with a substantial increase in the risk of VTE.\n\nCurrent guidelines recommend the use of low-molecular-weight heparin (LMWH), given subcutaneously, for the acute and long-term treatment of VTE in cancer patients.\n\nDue to the high risk for recurrence, cancer patients who experience VTE are candidates to indefinite treatment duration or to prolong treatment until cancer is completely cured. The availability of an oral anticoagulant treatment, as effective and safe as LMWH, would be a substantial advantage for patients with cancer who develop VTE.\n\nUnfortunately, the clinical trials on the treatment of VTE with the new oral anticoagulants included only a limited number of patients with cancer. Thus, whether the results obtained in the general population of patients with VTE also attain to cancer patients remains undefined.\n\nSubgroup analyses on the efficacy and safety profile of the anti-Xa oral agent apixaban for the treatment of VTE in cancer patients have been recently reported. Apixaban appeared to be at least as effective as LMWH given with and followed by vitamin K antagonists.\n\nTherefore, the aim of this study is to assess whether apixaban is non-inferior to the LMWH dalteparin for the treatment of newly diagnosed proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in patients with cancer.
REC name
Wales REC 3
REC reference
17/WA/0087
Date of REC Opinion
14 Jun 2017
REC opinion
Further Information Favourable Opinion