Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin

PharmEvo

Status and phase: Withdrawn; Phase 4

Conditions: Atrial Fibrillation; Mitral Valve Stenosis

Treatments: Drug: Rivaroxaban 15 mg; Drug: Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03673605

PE/NICVD/TS/Rivo/01

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Rivaroxaban

Experimental group

Treatment:

Drug: Rivaroxaban 15 mg

Warfarin

Active Comparator group

Treatment:

Drug: Warfarin