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Clinical Trial Summary

This prospective outcome study is designed to assess the safety of rivaroxaban in the pre-diagnosis phase of DVT.


Clinical Trial Description

This prospective outcome study is designed to assess the safety of rivaroxaban in the pre-diagnosis phase of DVT.

International guidelines suggest the use of low molecular weight heparin (LMWH) if the diagnostic process is expected to be delayed for more than 4 hours.

Rivaroxaban is a new DOAC that in clinical trials has proven to be non-inferior to LMWH and warfarin for the treatment of DVT with the added benefit of causing less major bleeding.

Because of its rapid onset of action and oral administration, rivaroxaban could be used instead of LMWH in the pre-diagnosis phase pending the results of the diagnostic test. However, the safety of a such proposed indication has to be proven before it can be adopted in clinical practice.

This study aims to determine the safety and feasibility of pre-diagnostic treatment with rivaroxaban. The primary outcome of this study "safety" is a composite endpoint of serious bleedings encountered within 48 hours after administration of rivaroxaban. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02486445
Study type Interventional
Source Ostfold Hospital Trust
Contact
Status Completed
Phase Phase 3
Start date March 2015
Completion date December 30, 2018

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