Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT02022527
Status:
UNKNOWN
Last Update Posted:
2013-12-30
First Post:
2013-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis
Sponsor:
Pharmacoeconomic Unit, Egypt
Organization:
Study Overview
Official Title:
Cost Effectiveness Analysis for Combination Of Aspirin And Warfarin Versus Warfarin Alone In Egyptian Patients With Heart Valve Prosthesis
Status:
UNKNOWN
Status Verified Date:
2013-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HVP
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: