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Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03673605
Recruitment Status : Withdrawn (No patients Enrollment)
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Mitral Valve Stenosis Atrial Fibrillation Drug: Rivaroxaban 15 mg Drug: Warfarin Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin in Patients With Atrial Fibrillation and Mitral Stenosis Among Pakistani Population
Actual Study Start Date : December 30, 2016
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Rivaroxaban Drug: Rivaroxaban 15 mg
Rivaroxiban in stroke prevention in patients with Mitral Stenosis and AF.

Active Comparator: Warfarin Drug: Warfarin
Warfarin in stroke prevention in patients with Mitral Stenosis and AF.

Primary Outcome Measures :
  1. Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging [ Time Frame: 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 :
  1. Adverse effects/complications of Rivaroxiban as compared to Warfarin in patients with Mitral Stenosis and AF. [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03673605

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National Institute of Cardiovascular
Karachi, Sindh, Pakistan
Sponsors and Collaborators
PharmEvo Pvt Ltd
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Responsible Party: PharmEvo Pvt Ltd Identifier: NCT03673605    
Other Study ID Numbers: PE/NICVD/TS/Rivo/01
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Mitral Valve Stenosis
Constriction, Pathologic
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Heart Valve Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action