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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 3

Age range

18 years - 95 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

625 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Ostfold Hospital Trust

Study start

2015-03 Actual

Primary completion

Nov 30, 2018 Actual

Study completion

Dec 30, 2018 Actual

First posted

Jul 1, 2015 Estimated

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.