Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis

Complications Due to Heart Valve Prosthesis Clinical Trial

— HVP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02022527
• Other study ID #: PEU2013
• Status: Recruiting
• Phase: Phase 4
• First received: December 20, 2013
• Last updated: December 26, 2013
• Start date: June 2013

Study information

• Verified date: December 2013
• Source: Pharmacoeconomic Unit, Egypt
• Contact: Gihan H Elsisi, Msc
• Phone: +201227366018
• Email: gihan-elsisi[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Complications Due to Heart Valve Prosthesis

Intervention

Drug:
• Acetyl Salicylic Acid

• Warfarin

• Placebo (for Aspirin)
Sugar pill manufactured to mimic 75 mg Aspirin

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacoeconomic Unit, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Mohamed H. Antithrombotic therapy in patients with prosthetic heart valves. Libyan J Med. 2009 Mar 1;4(1):54-6. doi: 10.4176/090115. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Valve Thrombosis		one year	No
Secondary	Major Systemic Embolism,		one year	No
Secondary	Non-fatal intracranial hemorrhage		one year	Yes
Secondary	Major extra cranial hemorrhage,		one year	Yes

External Links

•   Recommendations for Reporting Pharmacoeconomic Evaluations in Egypt