NCT02486445

Rivaroxaban for Scheduled Work-up of DVT - The Ri-Schedule Study

Rivaroxaban for Scheduled Work-up of Patients With Suspected Deep Venous Thrombosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 625 (actual)
• Sponsor: Ostfold Hospital Trust · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Deep Venous Thrombosis

Interventions

Type	Name	Description
DRUG	Rivaroxaban	Rivaroxaban 15 mg every 12 hours until the completion of the diagnostic work-up, which should not exceed 24 hours (maximum 2 tablets)

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-11-30
• Completion: 2018-12-30
• First posted: 2015-07-01
• Last updated: 2019-01-23

Locations

1 site across 1 country: Norway