Deep Vein ThrombosisPhase 3RIDTSNCT02722447
Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis
A Phase 3 study testing rivaroxaban in people with Deep Vein Thrombosis, run by Walter Ageno at 7 sites in Italy.
Trial summary
The treatment of isolated distal deep vein thrombosis remains one of the most debated issues in the field of venous thromboembolism and only very few studies have directly addressed the issue of treatment in objectively confirmed isolated distal deep vein thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- rivaroxaban
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- 7 sitesItaly
- Study dates
- Jan 2017to Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Objective diagnosis of isolate distal deep vein thrombosis within 72 hours from the evaluation for inclusion in the study and if any type of parenteral treatment was administered at therapeutic doses for 3 days or less (maximum accepted doses of low molecular weight heparin: 6 doses; of fondaparinux: 3 doses).
Who cannot join
- Age < 18 years
- Any absolute contraindication to anticoagulant treatment
- Pregnancy or breast-feeding
- Presence of active cancer
- Concomitant presence of proximal deep vein thrombosis or pulmonary embolism
- Any concomitant indication for long-term anticoagulant treatment
Show all 11Show fewer
- Creatinine clearance ≤30 ml/min, according to Cockcroft-Gault equation
- Cirrhosis Child-Pugh score B or C
- Liver disease associated with coagulopathy and high risk of bleeding
- Any other contraindication to rivaroxaban as per local SmPC
- Failure to provide written informed consent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Recruiting
Ospedale di Faenza
Faenza
Eugenio Bucherini
- Recruiting
Ospedale di Padova
Padua
Giuseppe Camporese, MD
- Recruiting
Ospedale di Pieve di Soligo
Pieve di Soligo
Giuseppe Zanatta
- Recruiting
Ospedale di Reggio Emilia
Reggio Emilia
Angelo Ghirarduzzi
- Recruiting
University of Siena
Siena
Roberto Cappelli, PhD
Roberto Cappelli
- Recruiting
Ospedale di Circolo
Varese, 21100
Giovanna Colombo, givacolo@hotmail.it
- Recruiting
University Of Insubria
Varese, 21100
Walter Ageno, MD, +39-0332-278594, agewal@yahoo.com
Francesco Dentali, MD
About this study
The treatment of isolated distal deep vein thrombosis remains one of the most debated issues in the field of venous thromboembolism and only very few studies have directly addressed the issue of treatment in objectively confirmed isolated distal deep vein thrombosis. Aim of this study is to assess the long-term risk of recurrent venous thrombotic events in patients with a first acute symptomatic isolated distal deep vein thrombosis of the leg treated with a standard (12 weeks) or with a shorter (6 weeks) duration of therapy with rivaroxaban.
- Conditions
- Deep Vein Thrombosis
- Being tested
- rivaroxaban, Placebo
- 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
Rivaroxaban 20 mg for 6 weeks
PlaceboDrug
Placebo for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Active comparator | Rivaroxaban 20 mg od for 6 weeks after an initial course of rivaroxaban for 6 weeks (15 mg bid for 3 weeks and 20 mg od for 3 weeks) Receives: Drug: rivaroxaban |
| Placebo | Experimental | Placebo for 6 weeks after an initial course of rivaroxaban for 6 weeks (15 mg bid for 3 weeks followed by 20 mg od for 3 weeks) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrent venous thromboembolism
Recurrent venous thromboembolism defined as new deep vein thrombosis, extension of distal deep vein thrombosis or pulmonary embolism
Measured: 24 months
Secondary outcomes (4)
Rate of major bleeding events
Measured: Until 2 days from the last intake of the study drug
Rate of clinically relevant non-major bleeding events
Measured: Until 2 days from the last intake of the study drug
Percentage of patients with residual vein occlusion
Measured: 3 months and 24 months
Rate of cardiovascular events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2019 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Ageno
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Walter Ageno, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722447
- Sponsor's protocol ID
- 2016-000958-36
- Other IDs
- 2016
- Acronym
- RIDTS
- Status last verified
- Nov 2018
- First submitted
- 13 Mar 2016
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ageno W, Bertu L, Bucherini E, Camporese G, Dentali F, Iotti M, Lessiani G, Parisi R, Prandoni P, Sartori M, Visona A, Bigagli E, Palareti G; RIDTS study group. Rivaroxaban treatment for six weeks versus three months in patients with symptomatic isolated distal deep vein thrombosis: randomised controlled trial. BMJ. 2022 Nov 23;379:e072623. doi: 10.1136/bmj-2022-072623.
PubMed 36520715
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis
- ClinicalTrials.gov ID
- NCT02722447
- Acronym / sponsor ID
- RIDTS / 2016-000958-36
- Conditions
- Deep Vein Thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Walter AgenoUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The treatment of isolated distal deep vein thrombosis remains one of the most debated issues in the field of venous thromboembolism and only very few studies have directly addressed the issue of treatment in objectively confirmed isolated distal deep vein thrombosis. Aim of this study is to assess the long-term risk of recurrent venous thrombotic events in patients with a first acute symptomatic isolated distal deep vein thrombosis of the leg treated with a standard (12 weeks) or with a shorter (6 weeks) duration of therapy with rivaroxaban.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Active comparator | Drug: rivaroxabanRivaroxaban 20 mg od for 6 weeks after an initial course of rivaroxaban for 6 weeks (15 mg bid for 3 weeks and 20 mg od for 3 weeks) |
| Placebo | Experimental | Drug: PlaceboPlacebo for 6 weeks after an initial course of rivaroxaban for 6 weeks (15 mg bid for 3 weeks followed by 20 mg od for 3 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Objective diagnosis of isolate distal deep vein thrombosis within 72 hours from the evaluation for inclusion in the study and if any type of parenteral treatment was administered at therapeutic doses for 3 days or less (maximum accepted doses of low molecular weight heparin: 6 doses; of fondaparinux: 3 doses).
Key exclusion criteria (11 listed)
- Age < 18 years
- Any absolute contraindication to anticoagulant treatment
- Pregnancy or breast-feeding
- Presence of active cancer
- Concomitant presence of proximal deep vein thrombosis or pulmonary embolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rivaroxabanRivaroxaban 20 mg for 6 weeks | Drug | Rivaroxaban |
| PlaceboPlacebo for 6 weeks | Drug | Placebo |
Primary outcome
Rate of recurrent venous thromboembolism
Time frame: 24 months
Recurrent venous thromboembolism defined as new deep vein thrombosis, extension of distal deep vein thrombosis or pulmonary embolism
4 secondary outcomes
Rate of major bleeding events
Time frame: Until 2 days from the last intake of the study drug
Rate of clinically relevant non-major bleeding events
Time frame: Until 2 days from the last intake of the study drug
Percentage of patients with residual vein occlusion
Time frame: 3 months and 24 months
Rate of cardiovascular events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Derived from this study: PubMed 36520715Ageno W, Bertu L, Bucherini E, Camporese G, Dentali F, Iotti M, Lessiani G, Parisi R, Prandoni P, Sartori M, Visona A, Bigagli E, Palareti G; RIDTS study group. Rivaroxaban treatment for six weeks versus three months in patients with symptomatic isolated distal deep vein thrombosis: randomised controlled trial. BMJ. 2022 Nov 23;379:e072623. doi: 10.1136/bmj-2022-072623.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rivaroxaban in people with Deep Vein Thrombosis, run by Walter Ageno at 7 sites in Italy.
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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorenza Bertù, PhD (0039 0332 278831, lorenza.bertu@uninsubria.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recurrent venous thromboembolism (time frame: 24 months). 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 NCT02722447, which also lists 1 linked publication.
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 27 Nov 2018.