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

Primary Purpose

Deep Vein Thrombosis

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
rivaroxaban
Placebo
Sponsored by
Walter Ageno
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale di FaenzaRecruiting
  • Ospedale di PadovaRecruiting
  • Ospedale di Pieve di SoligoRecruiting
  • Ospedale di Reggio EmiliaRecruiting
  • University of SienaRecruiting
  • Ospedale di CircoloRecruiting
  • University Of InsubriaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rivaroxaban

Placebo

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Rate of recurrent venous thromboembolism
Recurrent venous thromboembolism defined as new deep vein thrombosis, extension of distal deep vein thrombosis or pulmonary embolism

Secondary Outcome Measures

Rate of major bleeding events
Rate of clinically relevant non-major bleeding events
Percentage of patients with residual vein occlusion
Rate of cardiovascular events

Full Information

First Posted
March 13, 2016
Last Updated
November 24, 2018
Sponsor
Walter Ageno
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1. Study Identification

Unique Protocol Identification Number
NCT02722447
Brief Title
Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis
Acronym
RIDTS
Official Title
Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Walter Ageno

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Placebo
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
rivaroxaban
Intervention Description
Rivaroxaban 20 mg for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 6 weeks
Primary Outcome Measure Information:
Title
Rate of recurrent venous thromboembolism
Description
Recurrent venous thromboembolism defined as new deep vein thrombosis, extension of distal deep vein thrombosis or pulmonary embolism
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Rate of major bleeding events
Time Frame
Until 2 days from the last intake of the study drug
Title
Rate of clinically relevant non-major bleeding events
Time Frame
Until 2 days from the last intake of the study drug
Title
Percentage of patients with residual vein occlusion
Time Frame
3 months and 24 months
Title
Rate of cardiovascular events
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorenza Bertù, PhD
Phone
0039 0332 278831
Email
lorenza.bertu@uninsubria.it
Facility Information:
Facility Name
Ospedale di Faenza
City
Faenza
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugenio Bucherini
Facility Name
Ospedale di Padova
City
Padua
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Camporese, MD
Facility Name
Ospedale di Pieve di Soligo
City
Pieve di Soligo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Zanatta
Facility Name
Ospedale di Reggio Emilia
City
Reggio Emilia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelo Ghirarduzzi
Facility Name
University of Siena
City
Siena
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Cappelli, PhD
First Name & Middle Initial & Last Name & Degree
Roberto Cappelli
Facility Name
Ospedale di Circolo
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanna Colombo
Email
givacolo@hotmail.it
Facility Name
University Of Insubria
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter Ageno, MD
Phone
+39-0332-278594
Email
agewal@yahoo.com
First Name & Middle Initial & Last Name & Degree
Francesco Dentali, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis

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