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Comparison Between Xarelto Versus Warfarin in the Recanalization Rate of Deep Venous Thrombosis in Patients Legs. (DVT)

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ClinicalTrials.gov Identifier: NCT02704598
Recruitment Status : Recruiting
First Posted : March 10, 2016
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Rafael de Athayde Soares, Hospital do Servidor Publico Estadual

Brief Summary:
This is a prospective, randomized study, aiming to evaluate patients with Deep Venous Thrombosis in lower limbs and the recanalization rates evaluated with DUPLEX ultrasound, as so the clinical outcomes in patients submitted to oral anticoagulation with Rivaroxaban versus Warfarin.

Condition or disease Intervention/treatment Phase
Deep Venous Thrombosis Drug: Rivaroxaban Drug: Warfarin Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Recanalization Rate and Incidence of Postthrombotic Syndrome in Patients With Lower-limb Deep Venous Thrombosis Treated With Rivaroxaban or Warfarin
Actual Study Start Date : March 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Rivaroxaban
Patients with deep venous thrombosis using Rivaroxaban for 6 months, and then will be evaluated with DUPLEX SCAN to assess the recanalization rate, and also the clinical signs and symptoms.
Drug: Rivaroxaban
Evaluate the efficacy of the oral anticoagulants in the treatment of deep venous tromboses, assessing clinical signs and symptoms, as so the recanalization rate using DUPLEX SCAN.
Other Name: xarelto

Active Comparator: Warfarin
Patients with deep venous thrombosis using Warfarin for 6 months, and then will be evaluated wiht DUPLEX SCAN to assess the recanalization rate, and also the clinical signs and symptoms.
Drug: Warfarin
Evaluate the efficacy of the oral anticoagulants in the treatment of deep venous tromboses, assessing clinical signs and symptoms, as so the recanalization rate using DUPLEX SCAN.
Other Name: Marevan




Primary Outcome Measures :
  1. the long-term outcomes (after 12 months) in two groups of patients after treatment for DVT, by comparing the DUS-detected recanalization rates and the occurrence of PTS. [ Time Frame: 6 months after the diagnosis of deep venous thrombosis. ]
    The patients are evaluated within 6 months with Duplex ultrasound to assess the recanalization rate. The criteria to assess Deep venous thrombosis are defined as as visualization of thrombus and/or lack of complete compressibility of the vein. Thrombus involving popliteal and/or more proximal veins was classified as proximal Deep venous thrombosis (DVT). The US findings in DVT include: the presence of echoes within the vascular lumen; the veins in axial scans are not compressible. Pulsed Doppler and duplex Doppler combine the morphologic and functional study. Injury caused by DVT at the valvular level (postphlebitic syndrome) is visualized. Venous segments were examined whether they were occluded, partially recanalized, or totally recanalized, and the development of venous reflux was evaluated.


Secondary Outcome Measures :
  1. Clinical Signs and Symptoms in 84 patients.. [ Time Frame: 6 months the diagnosis of deep venous thrombosis. ]
    The patients are evaluated within 6 months with clinical examination, to evaluate presence of pain in lower limbs, swelling and varicose veins. The post-thrombotic syndrome is characterized by aching pain on standing, dependent oedema, and the frequent develop-ment of brawny, tender induration of the subcutaneous tissues of the medial lower limb, a condition that has been termed lipodermatosclerosis. Pruritus and eczematous skin changes are frequently present, and a proportion of patients develop secondary superficial varicose veins as the syndrome evolves.Ulceration, often precipitated by minor trauma, arises in a considerable number of patients and is characteristically chronic and indolent with a high recurrence rate, once healing has been achieved. Uncommonly, patients with persistent obstruction may experience venous claudication, a bursting pain in the leg during exercise, which, in some respects,mimics arterial claudication (Immelman & Jeffrey, 1984).



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Ages Eligible for Study:   21 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

The noninclusion criteria were: pregnancy, age < 18 years or > 80 years, chronic renal failure, chronic hepatic chronic failure, inferior vena cava thrombosis, contraindication for any type of anticoagulation, previous DVT on the ipsilateral affected limb, or any type of active cancer, and patients who refused to participate in the study.

The exclusion criteria were: several hemorrhagic complications that required the discontinuation of anticoagulation, death after < 30 days, allergic reaction to any anticoagulant, a diagnosis of active cancer during follow-up, loss to follow-up, difficulty in achieving proper anticoagulation due to patient nonadherence to the treatment protocol, and incomplete data.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704598


Contacts
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Contact: Rafael de Athayde Soares, MD, Dr. +5511999813931 ext 8226 rafaelsoon@hotmail.com
Contact: Marcelo Fernando Matielo, MD, PhD, Dr. +5511999018550 mmatielo@gmail.com

Locations
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Brazil
Hospital do Servidor Público Estadual de São Paulo Recruiting
São Paulo, SP, Brazil, 04028-000
Contact: Marcelo Fernando Matielo, PhD    +551199901-8550    mmatielo@gmail.com   
Contact: Roberto Sacilotto, PhD    +5511994948178      
Sponsors and Collaborators
Hospital do Servidor Publico Estadual
Investigators
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Principal Investigator: Rafael Athayde Soares, MD, Dr/ Hospital do Servidor Publico Estadual

Publications of Results:
Other Publications:
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Responsible Party: Rafael de Athayde Soares, Dr. Rafael de Athayde Soares, MD, Hospital do Servidor Publico Estadual
ClinicalTrials.gov Identifier: NCT02704598     History of Changes
Other Study ID Numbers: 123456
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We preserve confidential data.
Additional relevant MeSH terms:
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Warfarin
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action