Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-30

Study Completion Date

2017-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Rivaroxaban on Vascular FMD in Patients With Stable Atherosclerotic Vascular Diseases

NCT06986369

Atherosclerosis, Coronary

COMPLETED PHASE4

Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)

NCT02833948

Aortic Valve Stenosis Cardiovascular Diseases Heart Valve Diseases +2 more

COMPLETED PHASE3

Pharmacodynamic Effects of Low-dose Rivaroxaban With Antiplatelet Therapies

NCT03718429

Coronary Artery Disease Peripheral Arterial Disease Atrial Fibrillation

COMPLETED PHASE4

Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation

NCT03187197

Atrial Fibrillation

COMPLETED

The Impact of Factor Xa Inhibition on Thrombosis, Platelet Activation, and Endothelial Function in Peripheral Artery Disease

NCT05009862

Peripheral Arterial Disease

ACTIVE_NOT_RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitral Valve Stenosis Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rivaroxaban

Group Type EXPERIMENTAL

Rivaroxaban 15 mg

Intervention Type DRUG

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

Warfarin

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rivaroxaban 15 mg

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

Intervention Type DRUG

Warfarin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No