Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin

Atrial Fibrillation Clinical Trial

Official title:

Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin in Patients With Atrial Fibrillation and Mitral Stenosis Among Pakistani Population

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03673605
• Other study ID #: PE/NICVD/TS/Rivo/01
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 30, 2016
• Est. completion date: December 30, 2017

Study information

• Verified date: December 2016
• Source: PharmEvo Pvt Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Constriction, Pathologic
• Mitral Valve Stenosis

Intervention

Drug:
• Rivaroxaban 15 mg
Rivaroxiban in stroke prevention in patients with Mitral Stenosis and AF.
• Warfarin
Warfarin in stroke prevention in patients with Mitral Stenosis and AF.

Locations

Country	Name	City	State
Pakistan	National Institute of Cardiovascular	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
PharmEvo Pvt Ltd

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse effects/complications of Rivaroxiban as compared to Warfarin in patients with Mitral Stenosis and AF.		12 months