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Deep Venous ThrombosisPhase 3Ri-ScheduleNCT02486445

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

A Phase 3 study testing Rivaroxaban in people with Deep Venous Thrombosis, run by Ostfold Hospital Trust at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 95 years
Conditions the study is for
Deep Venous Thrombosis
What is being tested?
Rivaroxaban
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
625 participants
Where
1 siteNorway
Study dates
Mar 2015to 30 Dec 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 1- 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)
Show all 18Show fewer
  • 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.)
  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Ostfold Hospital Trust

    Fredrikstad, Østfold fylke, 1606

Other trials in Norway

About this study

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

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

Read the 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.

Being tested
Rivaroxaban
Keywords
Deep venous thrombosis, Rivaroxaban
Medical subject headings
Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivaroxabanDrug

    Also called Xarelto

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

Study groups in NCT02486445
Study groupRoleWhat they receive
RivaroxabanExperimentalRivaroxaban 15 mg every 12 hours until the completion of the diagnostic work-up, which should not exceed 24 hours.
Receives: Drug: Rivaroxaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Until 48 hours after last tablet

Secondary outcomes (3)

  1. Feasability rate

    Assessed by the proportion of patients who can be managed by a scheduled work-up

    Measured: 12 hours

  2. Failure rate

    Worsening in pre-existing complaints or developement of signs/symptoms of pulmonary embolism

    Measured: until 48 hours after last tablet

  3. 90-day outcome

    The 90-day outcome of the applied diagnostic strategy using Wells pre-test clinical probability, D-dimer and compression ultrasounography and safety of coagulation

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2015 (estimated)
  2. Study startMar 2015
  3. Primary completion30 Nov 2018
  4. Study completion30 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
625 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02486445
Sponsor's protocol ID
3304
Acronym
Ri-Schedule
Status last verified
Sep 2017
First submitted
25 Feb 2015
Last updated
23 Jan 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: There is no plan to share IPD

Publications

  • 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.

    PubMed 41116683

  • 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.

    PubMed 33057634

  • 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.

    PubMed 32502267

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban in people with Deep Venous Thrombosis, run by Ostfold Hospital Trust at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of serious bleedings and/or death related to bleeding (time frame: Until 48 hours after last tablet). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02486445, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.

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