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

NCT02486445 | Completed Phase 3 DMC

• 1 other identifier: 3304
• Study Type: interventional
• Target: 625
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Deep Venous Thrombosis

Keywords

Deep venous thrombosis; Rivaroxaban

Outcome Measures

Primary Outcomes (1)

• Rate of serious bleedings and/or death related to bleeding

  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.

  Until 48 hours after last tablet

Secondary Outcomes (3)

• Feasability rate

  12 hours

• Failure rate

  until 48 hours after last tablet

• 90-day outcome

  90 days

Study Arms (1)

Rivaroxaban

EXPERIMENTAL

Rivaroxaban 15 mg every 12 hours until the completion of the diagnostic work-up, which should not exceed 24 hours.

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

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

Also known as: Xarelto

Rivaroxaban

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive outpatients referred to ER because of suspected DVT
• years of age
• Signed informed consent

You may not qualify if:

• refuse to consent
• Patients with the criteria below will not be eligible for scheduled work-up:
• Duration of the diagnostic work-up is expected to last \< 2 hours
• Presence of active cancer or receiving chemotherapy for cancer
• Suspicion of coexisting clinical PE
• Suspicion of active bleeding (gastrointestinal bleeding or muscle hematoma)
• Signs of threatened circulation or having intractable pain in the lower extremity or may be considered as candidate for thrombolytic treatment
• Physician does not consider it safe to discharge the patient
• Presence of logistic factors that may hinder a scheduled work-up
• Presence of co-morbid conditions that require hospital admission
• Patient prefers not to be discharged before diagnosis is completed
• Glomerular Filtration Rate \< 45 ml/min
• Presence of contraindications to rivaroxaban including;
• Lesion or condition, if considered to be a significant risk for major bleeding e.g current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
• Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban etc.)

Sponsors & Collaborators

• Ostfold Hospital Trust: lead

Study Sites (1)

Ostfold Hospital Trust

Fredrikstad, Østfold fylke, 1606, Norway

Location

Related Publications (3)

• Mohamad H, Jorgensen CT, Ghanima W, Tavoly M, Fronas SG. Clinical use and safety of empiric anticoagulation during diagnostic work-up for deep vein thrombosis. Hematology. 2025 Dec;30(1):2573586. doi: 10.1080/16078454.2025.2573586. Epub 2025 Oct 20.

  PMID: 41116683 DERIVED

• Fronas SG, Jorgensen CT, Dahm AEA, Wik HS, Gleditsch J, Raouf N, Holst R, Klok FA, Ghanima W. Safety of a strategy combining D-dimer testing and whole-leg ultrasonography to rule out deep vein thrombosis. Blood Adv. 2020 Oct 27;4(20):5002-5010. doi: 10.1182/bloodadvances.2020002173.

  PMID: 33057634 DERIVED

• Fronas SG, Dahm AEA, Wik HS, Jorgensen CT, Gleditsch J, Raouf N, Holst R, Klok FA, Ghanima W. Safety and feasibility of rivaroxaban in deferred workup of patients with suspected deep vein thrombosis. Blood Adv. 2020 Jun 9;4(11):2468-2476. doi: 10.1182/bloodadvances.2020001556.

  PMID: 32502267 DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Waleed Ghanima, PhD

  Ostfold Hospital Trust

  STUDY DIRECTOR

• Nezar Raouf

  Ostfold Hopital Trust

  PRINCIPAL INVESTIGATOR

• Kristin Utne

  Ostfold Hospital Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: July 1, 2015
• Study Start: March 1, 2015
• Primary Completion: November 30, 2018
• Study Completion: December 30, 2018
• Last Updated: January 23, 2019

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)