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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
Sponsor:
Information provided by (Responsible Party):
Ostfold Hospital Trust

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

Condition or disease Intervention/treatment Phase
Deep Venous Thrombosis Drug: Rivaroxaban Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 625 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: Rivaroxaban
Rivaroxaban 15 mg every 12 hours until the completion of the diagnostic work-up, which should not exceed 24 hours.
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)
Other Name: Xarelto




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Feasability rate [ Time Frame: 12 hours ]
    Assessed by the proportion of patients who can be managed by a scheduled work-up

  2. Failure rate [ Time Frame: until 48 hours after last tablet ]
    Worsening in pre-existing complaints or developement of signs/symptoms of pulmonary embolism

  3. 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



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1- refuse to consent

Patients with the criteria below will not be eligible for scheduled work-up:

  1. Duration of the diagnostic work-up is expected to last < 2 hours
  2. Presence of active cancer or receiving chemotherapy for cancer
  3. Suspicion of coexisting clinical PE
  4. Suspicion of active bleeding (gastrointestinal bleeding or muscle hematoma)
  5. Signs of threatened circulation or having intractable pain in the lower extremity or may be considered as candidate for thrombolytic treatment
  6. Physician does not consider it safe to discharge the patient
  7. Presence of logistic factors that may hinder a scheduled work-up
  8. Presence of co-morbid conditions that require hospital admission
  9. Patient prefers not to be discharged before diagnosis is completed
  10. Glomerular Filtration Rate < 45 ml/min
  11. 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.)
    • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C.
    • Pregnancy/positive pregnancy test and breastfeeding (see section 4.6)

11. Hb < 11 g/dl 12. Presence of drug interaction with rivaroxaban including concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (e.g. ritonavir), acetylsalicylic acid at a dose higher than 160 mg or platelet aggregation inhibitors


Information from the National Library of Medicine

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


Locations
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Norway
Ostfold Hospital Trust
Fredrikstad, Ostfold, Norway, 1606
Sponsors and Collaborators
Ostfold Hospital Trust
Investigators
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Study Director: Waleed Ghanima, PhD Ostfold Hospital Trust
Principal Investigator: Nezar Raouf Ostfold Hopital Trust
Principal Investigator: Kristin Utne Ostfold Hospital Trust

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Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT02486445     History of Changes
Other Study ID Numbers: 3304
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD

Keywords provided by Ostfold Hospital Trust:
Deep venous thrombosis
Rivaroxaban

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants