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Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis (RIDTS)

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ClinicalTrials.gov Identifier: NCT02722447
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Walter Ageno, Università degli Studi dell'Insubria

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Drug: rivaroxaban Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis
Actual Study Start Date : January 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Active Comparator: 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)
Drug: rivaroxaban
Rivaroxaban 20 mg for 6 weeks

Experimental: 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)
Drug: Placebo
Placebo for 6 weeks




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Rate of major bleeding events [ Time Frame: Until 2 days from the last intake of the study drug ]
  2. Rate of clinically relevant non-major bleeding events [ Time Frame: Until 2 days from the last intake of the study drug ]
  3. Percentage of patients with residual vein occlusion [ Time Frame: 3 months and 24 months ]
  4. Rate of cardiovascular events [ Time Frame: 24 months ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  • 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

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): NCT02722447


Contacts
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Contact: Lorenza Bertù, PhD 0039 0332 278831 lorenza.bertu@uninsubria.it

Locations
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Italy
Ospedale di Faenza Recruiting
Faenza, Italy
Contact: Eugenio Bucherini         
Ospedale di Padova Recruiting
Padua, Italy
Contact: Giuseppe Camporese, MD         
Ospedale di Pieve di Soligo Recruiting
Pieve di Soligo, Italy
Contact: Giuseppe Zanatta         
Ospedale di Reggio Emilia Recruiting
Reggio Emilia, Italy
Contact: Angelo Ghirarduzzi         
University of Siena Recruiting
Siena, Italy
Contact: Roberto Cappelli, PhD         
Sub-Investigator: Roberto Cappelli         
Ospedale di Circolo Recruiting
Varese, Italy, 21100
Contact: Giovanna Colombo       givacolo@hotmail.it   
University Of Insubria Recruiting
Varese, Italy, 21100
Contact: Walter Ageno, MD    +39-0332-278594    agewal@yahoo.com   
Sub-Investigator: Francesco Dentali, MD         
Sponsors and Collaborators
Walter Ageno

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Responsible Party: Walter Ageno, Associate Professor of Medicine, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT02722447     History of Changes
Other Study ID Numbers: 2016-000958-36
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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