Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin

Phase 4

Withdrawn

• Conditions: Mitral Valve Stenosis; Atrial Fibrillation
• Interventions: Drug: Rivaroxaban 15 mg; Drug: Warfarin

• Registration Number: NCT03673605
• Lead Sponsor: PharmEvo Pvt Ltd

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

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-08
• Study Start: 2016-12-30
• Primary Completion: 2017-10-30
• Study Completion: 2017-12-30
• Study First Submitted QC: 2018-09-13
• Last Update Submitted: 2018-09-13
• Study First Posted: 2018-09-17
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban 15 mg	-
Warfarin	Warfarin	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse effects/complications of Rivaroxiban as compared to Warfarin in patients with Mitral Stenosis and AF.	12 months

Trial Locations

Locations (1)

National Institute of Cardiovascular; 🇵🇰 Karachi, Sindh, Pakistan