Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin
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|ClinicalTrials.gov Identifier: NCT03673605|
Recruitment Status : Withdrawn (No patients Enrollment)
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mitral Valve Stenosis Atrial Fibrillation||Drug: Rivaroxaban 15 mg Drug: Warfarin||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Drug: Rivaroxaban 15 mg
Rivaroxiban in stroke prevention in patients with Mitral Stenosis and AF.
|Active Comparator: Warfarin||
Warfarin in stroke prevention in patients with Mitral Stenosis and AF.
- 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
- Adverse effects/complications of Rivaroxiban as compared to Warfarin in patients with Mitral Stenosis and AF. [ Time Frame: 12 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT03673605
|National Institute of Cardiovascular|
|Karachi, Sindh, Pakistan|