NCT02722447

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2017

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

2.4 years

First QC Date

March 13, 2016

Last Update Submit

November 24, 2018

Conditions

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

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)

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)

Drug: Placebo

Interventions

rivaroxabanDRUG

Rivaroxaban 20 mg for 6 weeks

Rivaroxaban
PlaceboDRUG

Placebo for 6 weeks

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Ospedale di Faenza

Faenza, Italy

RECRUITING

Ospedale di Padova

Padua, Italy

RECRUITING

Ospedale di Pieve di Soligo

Pieve di Soligo, Italy

RECRUITING

Ospedale di Reggio Emilia

Reggio Emilia, Italy

RECRUITING

University of Siena

Siena, Italy

RECRUITING

Ospedale di Circolo

Varese, 21100, Italy

RECRUITING

University Of Insubria

Varese, 21100, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36520715DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Lorenza Bertù, PhD

CONTACT

0039 0332 278831lorenza.bertu@uninsubria.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

March 13, 2016

First Posted

March 30, 2016

Study Start

January 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2021

Last Updated

November 27, 2018

Record last verified: 2018-11

Locations

IT(7)