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Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02022527
Acronym
HVP
Enrollment
300
Registered
2013-12-27
Start date
2013-06-30
Completion date
Unknown
Last updated
2013-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications Due to Heart Valve Prosthesis

Keywords

Cost-Effectiveness,, Heart valve prosthesis, Warfarin,, Aspirin,, 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.

Interventions

DRUGWarfarin

Sugar pill manufactured to mimic 75 mg Aspirin

Sponsors

Pharmacoeconomic Unit, Egypt
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Valve Thrombosisone year

Secondary

MeasureTime frame
Major Systemic Embolism,one year
Non-fatal intracranial hemorrhageone year
Major extra cranial hemorrhage,one year

Countries

Egypt

Contacts

Primary ContactGihan H Elsisi, Msc
gihan-elsisi@hotmail.com+201227366018
Backup ContactManal H Elhamamsy, PhD
M_elhamamsy@hotmail.com+201005257416

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026