Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin

September 13, 2018 updated by: PharmEvo Pvt Ltd

Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin in Patients With Atrial Fibrillation and Mitral Stenosis Among Pakistani Population

Title: Efficacy and safety of rivaroxiban compare with vitamin K antagonist warfarin in patients with atrial fibrillation and mitral stenosis among Pakistani population.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Atrial fibrillation is associated with an increase in the risk of ischemic stroke by a factor of four to five and accounts for up to 15% of strokes in persons of all ages and 30% in persons over the age of 80 years. The use of vitamin K antagonists is highly effective for stroke prevention in patients with non-valvular atrial fibrillation and is recommended for persons at increased risk. However, food and drug interactions necessitate frequent coagulation monitoring and dose adjustments, requirements that make it difficult for many patients to use such drugs in clinical practice.

Rivaroxaban is a direct factor Xa inhibitor that may provide more consistent and predictable anticoagulation than warfarin. It has been reported to prevent venous thromboembolism more effectively than enoxaparin in patients undergoing orthopedic surgery and was non-inferior to enoxaparin followed by warfarin in a study involving patients with established venous thrombosis. This trial was designed to compare once-daily oral rivaroxaban with dose-adjusted warfarin for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation who were at moderate-to-high risk for stroke

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • National Institute of Cardiovascular

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both gender
  • Age from 18 years up to 55 years
  • Rheumatic MS (Mild moderate severe) Hemodynamic ally stable patients
  • Associated AF or flutter documented on ECG
  • Post PTMC or M com
  • Not previously enrolled in any trial or study on NOACS
  • Willing to participate

Exclusion Criteria:

  • Rheumatic valve other than MS
  • Prosthetic Mitral Valve Surgery
  • Previous TIA or stroke
  • Plan for valve replacement within six months
  • Pregnancy
  • History of bleeding complication
  • High Risk of bleeding complication
  • Allergic to study drug
  • Anemia (HB less than 10 g/dl)
  • Raised SGPT > 2xUNL
  • Creatinine clearance <30ml/min
  • Not willing to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Warfarin
Drug: Warfarin
Warfarin in stroke prevention in patients with Mitral Stenosis and AF.
Experimental: Rivaroxaban
Drug: Rivaroxaban 15 mg
Rivaroxiban in stroke prevention in patients with Mitral Stenosis and AF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging
Time Frame: 12 months
Intracranial bleeding: symptomatic hemorrhage confirmed by CT or MRI or asymptomatic hemorrhage on follow-up GRE or SWI imaging at 1 month Recurrent ischemic lesion: symptomatic ischemic stroke confirmed by relevant neuroimagings or asymptomatic recurrent ischemic lesion on follow-up or FLAIR imaging at 12 month
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse effects/complications of Rivaroxiban as compared to Warfarin in patients with Mitral Stenosis and AF.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PharmEvo Pvt Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2016

Primary Completion (Actual)

October 30, 2017

Study Completion (Actual)

December 30, 2017

Study Registration Dates

First Submitted

December 8, 2016

First Submitted That Met QC Criteria

September 13, 2018

First Posted (Actual)

September 17, 2018

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PE/NICVD/TS/Rivo/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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