Clinical trial NCT02022527: Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis
Official title: Cost Effectiveness Analysis for Combination Of Aspirin And Warfarin Versus Warfarin Alone In Egyptian Patients With Heart Valve Prosthesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Complications Due to Heart Valve Prosthesis
Keywords: Cost-Effectiveness,
Heart valve prosthesis
Warfarin,
Aspirin,
Egypt
Lead sponsor: Pharmacoeconomic Unit, Egypt
Sponsor class: OTHER_GOV
First posted: 2013-12-27
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Valve Thrombosis
timeFrame: one year
Secondary outcomes:
measure: Major Systemic Embolism,
timeFrame: one year
measure: Non-fatal intracranial hemorrhage
timeFrame: one year
measure: Major extra cranial hemorrhage,
timeFrame: one year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
affiliation: Pharmacoeconomic Unit
name: Gihan H Elsisi, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of pharmacy, Ain Shams University
name: Manal H Elhamamsy, PhD
role: STUDY_CHAIR
affiliation: Central Administration for Pharmaceutical Affairs
name: Mohamed ME Mazar, PhD
role: STUDY_DIRECTOR
References:
citation: Mohamed H. Antithrombotic therapy in patients with prosthetic heart valves. Libyan J Med. 2009 Mar 1;4(1):54-6. doi: 10.4176/090115.