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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.
The measurements will be assessed:
A- Number of patients improved during follow up:
B-Costs:
Direct medical costs will be assessed directly from hospital's records and tender lists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination | Experimental | 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. |
|
| Warfarin | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetyl Salicylic Acid | Drug |
|
| |
| Warfarin |
| Measure | Description | Time Frame |
|---|---|---|
| Valve Thrombosis | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Major Systemic Embolism, | one year | |
| Non-fatal intracranial hemorrhage | one year | |
| Major extra cranial hemorrhage, |
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Inclusion Criteria:
Patients operated in Ain Shams University Hospitals for aortic and/ or mitral valve replacement.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gihan H Elsisi, Msc | Contact | +201227366018 | gihan-elsisi@hotmail.com | |
| Manal H Elhamamsy, PhD | Contact | +201005257416 | M_elhamamsy@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gihan H Elsisi, Msc | Pharmacoeconomic Unit | Principal Investigator |
| Manal H Elhamamsy, PhD | Faculty of pharmacy, Ain Shams University | Study Chair |
| Mohamed ME Mazar, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University hospitals | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21483507 | Background | Mohamed H. Antithrombotic therapy in patients with prosthetic heart valves. Libyan J Med. 2009 Mar 1;4(1):54-6. doi: 10.4176/090115. |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Drug |
|
|
| Placebo (for Aspirin) | Drug | Sugar pill manufactured to mimic 75 mg Aspirin |
|
| one year |
| Central Administration for Pharmaceutical Affairs |
| Study Director |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |