Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis

Phase 4

• Conditions: Complications Due to Heart Valve Prosthesis
• Interventions: Drug: Acetyl Salicylic Acid; Drug: Placebo (for Aspirin); Drug: Warfarin

• Registration Number: NCT02022527
• Lead Sponsor: Pharmacoeconomic Unit, Egypt

Brief Summary

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

The measurements will be assessed:

A- Number of patients improved during follow up:

1. Demographic data

2. Diagnosis

3. Laboratory tests (CBC, Prothrombin Time, liver and renal function tests)

4. Echocardiography profile

B-Costs:

Direct medical costs will be assessed directly from hospital's records and tender lists.

Study Timeline

• Study Start: 2013-06
• Status Verified: 2013-12
• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2013-12-20
• Last Update Submitted: 2013-12-26
• Study First Posted: 2013-12-27
• Last Update Posted: 2013-12-30
• Primary Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination	Acetyl Salicylic Acid	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.
Warfarin	Placebo (for Aspirin)	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.
Combination	Warfarin	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.
Warfarin	Warfarin	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.

Primary Outcome Measures

Name	Time	Method
Valve Thrombosis	one year

Secondary Outcome Measures

Name	Time	Method
Major Systemic Embolism,	one year
Major extra cranial hemorrhage,	one year
Non-fatal intracranial hemorrhage	one year

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Egypt