- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02022527
Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis (HVP)
December 26, 2013 updated by: Gihan Hamdy Elsisi, Pharmacoeconomic Unit, Egypt
Cost Effectiveness Analysis for Combination Of Aspirin And Warfarin Versus Warfarin Alone In Egyptian Patients With Heart Valve Prosthesis
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gihan H Elsisi, Msc
- Phone Number: +201227366018
- Email: gihan-elsisi@hotmail.com
Study Contact Backup
- Name: Manal H Elhamamsy, PhD
- Phone Number: +201005257416
- Email: M_elhamamsy@hotmail.com
Study Locations
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Cairo, Egypt
- Recruiting
- Ain Shams University Hospitals
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Contact:
- Ahmed Hassouna, MD
- Phone Number: +201223105271
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Sub-Investigator:
- Basma Awad, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Other Names:
Other Names:
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Active Comparator: 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.
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Other Names:
Sugar pill manufactured to mimic 75 mg Aspirin
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Valve Thrombosis
Time Frame: one year
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one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Major Systemic Embolism,
Time Frame: one year
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one year
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Non-fatal intracranial hemorrhage
Time Frame: one year
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one year
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Major extra cranial hemorrhage,
Time Frame: one year
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gihan H Elsisi, Msc, Pharmacoeconomic Unit
- Study Chair: Manal H Elhamamsy, PhD, Faculty of Pharmacy, Ain Shams University
- Study Director: Mohamed ME Mazar, PhD, Central Administration for Pharmaceutical Affairs
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Anticipated)
July 1, 2014
Study Registration Dates
First Submitted
December 20, 2013
First Submitted That Met QC Criteria
December 20, 2013
First Posted (Estimate)
December 27, 2013
Study Record Updates
Last Update Posted (Estimate)
December 30, 2013
Last Update Submitted That Met QC Criteria
December 26, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Dermatologic Agents
- Antifungal Agents
- Keratolytic Agents
- Anticoagulants
- Aspirin
- Salicylic Acid
- Warfarin
- Salicylates
Other Study ID Numbers
- PEU2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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