Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin

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• Status: Withdrawn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: Atrial Fibrillation; Mitral Valve Stenosis
• Intervention / Treatment: Drug: Rivaroxaban 15 mg; Drug: Warfarin

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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.	12 months

Collaborators and Investigators

• Sponsor: PharmEvo Pvt Ltd

Study record dates

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: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Arrhythmias, Cardiac; Heart Valve Diseases; Atrial Fibrillation; Constriction, Pathologic; Mitral Valve Stenosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Warfarin
• Other Study ID Numbers: PE/NICVD/TS/Rivo/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes