Cost Effectiveness Analysis for Combination Of Aspirin And Warfarin Versus Warfarin Alone In Egyptian Patients With Heart Valve Prosthesis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Valve Thrombosis
研究概览
简要总结
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.
详细描述
The measurements will be assessed:
A- Number of patients improved during follow up:
- Demographic data
- Diagnosis
- Laboratory tests (CBC, Prothrombin Time, liver and renal function tests)
- Echocardiography profile
B-Costs:
Direct medical costs will be assessed directly from hospital's records and tender lists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients operated in Ain Shams University Hospitals for aortic and/ or mitral valve replacement.
排除标准
- •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.
研究组 & 干预措施
Combination
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.
干预措施: Acetyl Salicylic Acid (Drug)
Combination
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.
干预措施: Warfarin (Drug)
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.
干预措施: Warfarin (Drug)
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.
干预措施: Placebo (for Aspirin) (Drug)
结局指标
主要结局
Valve Thrombosis
时间窗: one year
次要结局
- Major extra cranial hemorrhage,(one year)
- Major Systemic Embolism,(one year)
- Non-fatal intracranial hemorrhage(one year)
研究者
Gihan Hamdy Elsisi
Head of Pharmacoeconomic Unit
Pharmacoeconomic Unit, Egypt