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

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 Overview

• Status: Unknown
• Conditions: Deep Vein Thrombosis
• Intervention / Treatment: Drug: rivaroxaban; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 1100
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of recurrent venous thromboembolism	Recurrent venous thromboembolism defined as new deep vein thrombosis, extension of distal deep vein thrombosis or pulmonary embolism	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of major bleeding events	Until 2 days from the last intake of the study drug
Rate of clinically relevant non-major bleeding events	Until 2 days from the last intake of the study drug
Percentage of patients with residual vein occlusion	3 months and 24 months
Rate of cardiovascular events	24 months

Collaborators and Investigators

• Sponsor: Walter Ageno

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: March 13, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 24, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 2016-000958-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No