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Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin

Primary Purpose

Mitral Valve Stenosis, Atrial Fibrillation

Status
Withdrawn
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Rivaroxaban 15 mg
Warfarin
Sponsored by
PharmEvo Pvt Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Stenosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Cardiovascular

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rivaroxaban

Warfarin

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging
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

Secondary Outcome Measures

Adverse effects/complications of Rivaroxiban as compared to Warfarin in patients with Mitral Stenosis and AF.

Full Information

First Posted
December 8, 2016
Last Updated
September 13, 2018
Sponsor
PharmEvo Pvt Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03673605
Brief Title
Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin
Official Title
Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin in Patients With Atrial Fibrillation and Mitral Stenosis Among Pakistani Population
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No patients Enrollment
Study Start Date
December 30, 2016 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmEvo Pvt Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Stenosis, Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban
Arm Type
Experimental
Arm Title
Warfarin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 15 mg
Intervention Description
Rivaroxiban in stroke prevention in patients with Mitral Stenosis and AF.
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
Warfarin in stroke prevention in patients with Mitral Stenosis and AF.
Primary Outcome Measure Information:
Title
Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adverse effects/complications of Rivaroxiban as compared to Warfarin in patients with Mitral Stenosis and AF.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Institute of Cardiovascular
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin

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