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Withdrawn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
About this trial
This is an interventional treatment trial for Mitral Valve Stenosis
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.
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
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Withdrawn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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