NCT03673605

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: PharmEvo Pvt Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Conditions

• Mitral Valve Stenosis
• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Rivaroxaban 15 mg	Rivaroxiban in stroke prevention in patients with Mitral Stenosis and AF.
DRUG	Warfarin	Warfarin in stroke prevention in patients with Mitral Stenosis and AF.

Timeline

• Start date: 2016-12-30
• Primary completion: 2017-10-30
• Completion: 2017-12-30
• First posted: 2018-09-17
• Last updated: 2018-09-17

Locations

1 site across 1 country: Pakistan