Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis
NCT ID: NCT02722447
Last Updated: 2018-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1100 participants
INTERVENTIONAL
2017-01-31
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rivaroxaban
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)
rivaroxaban
Rivaroxaban 20 mg for 6 weeks
Placebo
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)
Placebo
Placebo for 6 weeks
Interventions
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rivaroxaban
Rivaroxaban 20 mg for 6 weeks
Placebo
Placebo for 6 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Walter Ageno
OTHER
Responsible Party
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Walter Ageno
Associate Professor of Medicine
Locations
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Ospedale di Faenza
Faenza, , Italy
Ospedale di Padova
Padua, , Italy
Ospedale di Pieve di Soligo
Pieve di Soligo, , Italy
Ospedale di Reggio Emilia
Reggio Emilia, , Italy
University of Siena
Siena, , Italy
Ospedale di Circolo
Varese, , Italy
University Of Insubria
Varese, , Italy
Countries
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Central Contacts
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Facility Contacts
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Eugenio Bucherini
Role: primary
Giuseppe Camporese, MD
Role: primary
Giuseppe Zanatta
Role: primary
Angelo Ghirarduzzi
Role: primary
Roberto Cappelli, PhD
Role: primary
References
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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.
Other Identifiers
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2016-000958-36
Identifier Type: -
Identifier Source: org_study_id
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