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Rivaroxaban vs Warfarin in Patients With Metallic Prosthesis

NCT03566303 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-05-15

No results posted yet for this study

Summary

Mechanical heart valves (MHV) demand lifelong anticoagulation with vitamin K antagonists (VKA) due to the high thrombogenicity of the prosthesis. Rivaroxaban has previously been tested in experimental and animal models with encouraging results. The investigators recently sent for publication an experiment with 7 patients who used rivaroxaban in metallic prosthesis with encouraging results. In this way it was decided to do a randomized non-inferiority clinical trial comparing rivaroxaban with warfarin in patients with metallic prosthesis.

Conditions

  • Prostheses and Implants
  • Stroke
  • Valve Heart Disease
  • Anticoagulants and Bleeding Disorders

Interventions

DRUG

Rivaroxaban 15 mg

Rivaroxaban 15 mg BID

DRUG

Warfarin

Warfarin

Sponsors & Collaborators

  • Hospital Geral Roberto Santos

    lead OTHER

Principal Investigators

  • Andre Duraes, PhD · Federal University of Bahia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2020-04-26
Completion
2020-04-26

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03566303 on ClinicalTrials.gov