Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin

NCT03673605 | Withdrawn Phase 4 DMC

• 1 other identifier: PE/NICVD/TS/Rivo/01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Stenosis; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse effects/complications of Rivaroxiban as compared to Warfarin in patients with Mitral Stenosis and AF.

  12 months

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

Drug: Rivaroxaban 15 mg

Warfarin

ACTIVE COMPARATOR

Drug: Warfarin

Interventions

Rivaroxaban 15 mg DRUG

Rivaroxiban in stroke prevention in patients with Mitral Stenosis and AF.

Rivaroxaban

Warfarin DRUG

Warfarin in stroke prevention in patients with Mitral Stenosis and AF.

Warfarin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PharmEvo Pvt Ltd: lead

Study Sites (1)

National Institute of Cardiovascular

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Mitral Valve Stenosis; Atrial Fibrillation

Interventions

Rivaroxaban; Warfarin

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: September 17, 2018
• Study Start: December 30, 2016
• Primary Completion: October 30, 2017
• Study Completion: December 30, 2017
• Last Updated: September 17, 2018

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)