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

NCT02704598 | Unknown DMC

• 1 other identifier: 123456
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Venous Thrombosis

Outcome Measures

Primary Outcomes (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.

  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.

  6 months after the diagnosis of deep venous thrombosis.

Secondary Outcomes (1)

• Clinical Signs and Symptoms in 84 patients..

  6 months the diagnosis of deep venous thrombosis.

Study Arms (2)

Rivaroxaban

ACTIVE COMPARATOR

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

Warfarin

ACTIVE COMPARATOR

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

Interventions

Rivaroxaban DRUG

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.

Also known as: xarelto

Rivaroxaban

Warfarin DRUG

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.

Also known as: Marevan

Warfarin

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Hospital do Servidor Publico Estadual: lead

Study Sites (1)

Hospital do Servidor Público Estadual de São Paulo

São Paulo, São Paulo, 04028-000, Brazil

RECRUITING

Related Publications (3)

• Rivaroxaban (Xarelto): Treatment of Venous Thromboembolic Events (Deep Vein Thrombosis [DVT], Pulmonary Embolism [PE]) and Prevention of Recurrent DVT and PE [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2015 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK344331/

  PMID: 26913324 BACKGROUND

• Isaacs AN, Doolin M, Morse C, Shiltz E, Nisly SA. Medication utilization evaluation of dabigatran and rivaroxaban within a large, multi-center health system. Am J Health Syst Pharm. 2016 Mar 1;73(5 Suppl 1):S35-41. doi: 10.2146/sp150031.

  PMID: 26896524 BACKGROUND

• Finks SW, Trujillo TC, Dobesh PP. Management of Venous Thromboembolism: Recent Advances in Oral Anticoagulation Therapy. Ann Pharmacother. 2016 Jun;50(6):486-501. doi: 10.1177/1060028016632785. Epub 2016 Feb 25.

  PMID: 26917821 RESULT

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Rivaroxaban; Warfarin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Rafael Athayde Soares, MD, Dr/

  Hospital do Servidor Publico Estadual

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael de Athayde Soares, MD, Dr.

CONTACT

+5511999813931; rafaelsoon@hotmail.com

Marcelo Fernando Matielo, MD, PhD, Dr.

CONTACT

+5511999018550; mmatielo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Rafael de Athayde Soares, MD

Study Record Dates

• First Submitted: February 28, 2016
• First Posted: March 10, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: October 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)