A Phase 4 interventional study of Acetyl Salicylic Acid and Warfarin in Complications Due to Heart Valve Prosthesis, sponsored by Pharmacoeconomic Unit, Egypt. Status unknown at 1 site in Egypt. Open to participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-12-30.
Sponsored by Pharmacoeconomic Unit, Egypt · Phase 4, Interventional, and Prevention
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.
This is the only study on the registry with Pharmacoeconomic Unit, Egypt as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients operated in Ain Shams University Hospitals for aortic and/ or mitral valve replacement.
Exclusion Criteria:
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.
Drug: Acetyl Salicylic Acid · 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.
Drug: Warfarin · Drug: Placebo (for Aspirin)
Also known as: Aspirin
Also known as: Marevan
Sugar pill manufactured to mimic 75 mg Aspirin
Valve Thrombosis
Time frame: one year
Major Systemic Embolism,
Time frame: one year
Non-fatal intracranial hemorrhage
Time frame: one year
Major extra cranial hemorrhage,
Time frame: one year
This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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