RIDTS Study - Rivaroxaban for the treatment of symptomatic Isolated Distal deep vein Thrombosis

Phase 1

• Conditions: SYMPTOMATIC ISOLATED DISTAL DEEP VEIN THROMBOSIS; MedDRA version: 21.1Level: LLTClassification code 10049915Term: Deep venous thrombosis distalSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-000958-36-IT
• Lead Sponsor: DIPARTIMENTO DI MEDICINA CLINICA E SPERIMENTALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

Diagnosis of thrombosis in one or more infra-popliteal deep veins of the leg (including distal thromboses that reach the trifurcation area or the muscular ones). Diagnosis should be made by an ultrasonographic study extended to the whole deep vein system of both legs.
Patients are eligible only if the diagnosis of IDDVT was obtained 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 LMWH: 6 doses; of fondaparinux: 3 doses).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 550

Exclusion Criteria

1.Age < 18 years
2.Any absolute contraindication to anticoagulant treatment
3.Pregnancy or breast-feeding
4.Presence of active cancer
5.Concomitant presence of proximal DVT or pulmonary embolism
6.Any concomitant indication for long-term anticoagulant treatment
7.Creatinine clearance =30 ml/min, according to Cockcroft-Gault equation
8.Cirrhosis Child-Pugh score B or C
9.Liver disease associated with coagulopathy and high risk of bleeding
10.Any other contraindication to rivaroxaban as per local SmPC
11.Failure to provide written informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified