Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis

Deep Vein Thrombosis Clinical Trial

— RIDTS  

Official title:

Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02722447
• Other study ID #: 2016-000958-36
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: June 2021

Study information

• Verified date: November 2018
• Source: Università degli Studi dell'Insubria
• Contact: Lorenza Bertù, PhD
• Phone: 0039 0332 278831
• Email: lorenza.bertu[@]uninsubria.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: June 2021
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• rivaroxaban
Rivaroxaban 20 mg for 6 weeks
• Placebo
Placebo for 6 weeks

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Walter Ageno

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of major bleeding events		Until 2 days from the last intake of the study drug
Secondary	Rate of clinically relevant non-major bleeding events		Until 2 days from the last intake of the study drug
Secondary	Percentage of patients with residual vein occlusion		3 months and 24 months
Secondary	Rate of cardiovascular events		24 months