Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis

Study Overview
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Brief Summary
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The combined Antiplatelet and Anticoagulant treatment decreased thrombus formation and overall mortality. Also the initiation of an efficacious early anticoagulation protocol is important because of its potential impact on the rate of early thromboembolic complications after mechanical valve implantation. An important question that remains to be answered is whether the combination would be cost effective than Warfarin alone, with a reduction in major bleeding. In addition, the knowledge about its cost-effectiveness has not yet been established in Egypt. The aim of this trial based economic evaluation is to conduct a cost-effectiveness analysis for combination of low-dose Aspirin and Warfarin versus Warfarin alone in prosthetic valve patients from the medical provider perspective specially that a misconception is still existed between the physicians in Egypt that the cost of complications is not worthy so our main aim is to test the cost of complications.

Detailed Description
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The measurements will be assessed: A- Number of patients improved during follow up: Demographic data Diagnosis Laboratory tests (CBC, Prothrombin Time, liver and renal function tests) Echocardiography profile B-Costs: Direct medical costs will be assessed directly from hospital's records and tender lists.

Official Title
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Cost Effectiveness Analysis for Combination Of Aspirin And Warfarin Versus Warfarin Alone In Egyptian Patients With Heart Valve Prosthesis

Conditions
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Complications Due to Heart Valve Prosthesis

Intervention / Treatment
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* Drug: Acetyl Salicylic Acid
* Drug: Warfarin
* Drug: Placebo (for Aspirin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients operated in Ain Shams University Hospitals for aortic and/ or mitral valve replacement. Exclusion Criteria: Congenital blood disorders, Hemophilia. Advanced liver disease Advanced renal disease (dialysis patients) Aspirin sensitivity Autoimmune diseases Biological bioprosthesis valves Non-compliant & Drop out patient Pregnant women Caucasians.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination<br>Warfarin tablets adjusted according to international normalized ratio (INR) (2 for Aortic Valve Replacement & 2.5-3 for Mitral Valve Replacement, 2.5-3.5 for Double Valve Replacement) and oral 75 mg Acetyl Salicylic Acid tablets daily long life. | Drug: Acetyl Salicylic Acid<br> <br> * Other names: Aspirin;Drug: Warfarin<br> <br> * Other names: Marevan;|
| Active Comparator: Warfarin<br>Warfarin tablets adjusted according to INR (2 for Aortic Valve Replacement & 2.5-3 for Mitral Valve Replacement, 2.5-3.5 for Double Valve Replacement) and placebo long life. | Drug: Warfarin<br> <br> * Other names: Marevan;Drug: Placebo (for Aspirin)<br>* Sugar pill manufactured to mimic 75 mg Aspirin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valve Thrombosis |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Systemic Embolism, |  | one year | 
| Non-fatal intracranial hemorrhage |  | one year | 
| Major extra cranial hemorrhage, |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cost-Effectiveness,, Heart valve prosthesis, Warfarin,, Aspirin,, Egypt