Venous thromboembolism (VTE) is the third leading cause of death due to circulatory diseases, only behind of myocardial infarction and stroke. Since the publication of the CPMP guidance on clinical investigation of medicinal products for the treatment of venous thromboembolic disease 

[CPMP/EWP/563/98] in 2000, there has been intense research in this field. An update of the mentioned guideline is considered necessary to adapt its content to current scientific knowledge and to harmonise it with the content of new or revised EMA guidelines related to clinical investigation with antithrombotics.


The update includes: a) the distinction between initial and extended treatment of VTE, and between treatment of deep vein thrombosis (DVT) and superficial vein thrombosis (sVT), with a discussion on the need for specific studies in each of these situations and in certain special populations (e.g.: VTE associated to cancer and/or central venous catheters, VTE during pregnancy or childhood); b) current place of alternative imaging techniques for diagnosis of VTE; c) suitable control drugs that may be used in comparative trials; d) standardized definition of bleeding events and its assessment, as well as detailed description of methods for measuring blood loss and timing for collection of data; e) inclusion of additional secondary safety outcomes of clinical importance for new antithrombotics, like hepatic events or arterial thromboembolism.



Posted on the EMA website on 1 April 2015