Rivaroxaban for Scheduled Work-up of DVT - The Ri-Schedule Study (Ri-Schedule)
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|ClinicalTrials.gov Identifier: NCT02486445|
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Deep Venous Thrombosis||Drug: Rivaroxaban||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||625 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rivaroxaban for Scheduled Work-up of Patients With Suspected Deep Venous Thrombosis|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||November 30, 2018|
|Actual Study Completion Date :||December 30, 2018|
Rivaroxaban 15 mg every 12 hours until the completion of the diagnostic work-up, which should not exceed 24 hours.
Rivaroxaban 15 mg every 12 hours until the completion of the diagnostic work-up, which should not exceed 24 hours (maximum 2 tablets)
Other Name: Xarelto
- Rate of serious bleedings and/or death related to bleeding [ Time Frame: Until 48 hours after last tablet ]Serious bleedings and/or death related to bleeding encountered within 48 hours after the last rivaroxaban tablet was ingested in patients in whom DVT was excluded or until the ingestion of first tablet of oral anticoagulation or application of IV/SC heparin in those in whom DVT is confirmed.
- Feasability rate [ Time Frame: 12 hours ]Assessed by the proportion of patients who can be managed by a scheduled work-up
- Failure rate [ Time Frame: until 48 hours after last tablet ]Worsening in pre-existing complaints or developement of signs/symptoms of pulmonary embolism
- 90-day outcome [ Time Frame: 90 days ]The 90-day outcome of the applied diagnostic strategy using Wells pre-test clinical probability, D-dimer and compression ultrasounography and safety of coagulation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486445
|Ostfold Hospital Trust|
|Fredrikstad, Ostfold, Norway, 1606|
|Study Director:||Waleed Ghanima, PhD||Ostfold Hospital Trust|
|Principal Investigator:||Nezar Raouf||Ostfold Hopital Trust|
|Principal Investigator:||Kristin Utne||Ostfold Hospital Trust|