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HVP: Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis

Sponsor
Pharmacoeconomic Unit, Egypt (Other)
Overall Status
Unknown status
CT.gov ID
NCT02022527
Collaborator
(none)
300
Enrollment
1
Location
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Acetyl Salicylic Acid
  • Drug: Warfarin
  • Drug: Placebo (for Aspirin)
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Cost Effectiveness Analysis for Combination Of Aspirin And Warfarin Versus Warfarin Alone In Egyptian Patients With Heart Valve Prosthesis
Study Start Date :
Jun 1, 2013
Anticipated Primary Completion Date :
Jul 1, 2014

Arms and Interventions

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.

Drug: Acetyl Salicylic Acid
Other Names:
  • Aspirin

    • Drug: Warfarin
    Other Names:
  • Marevan

    		•
    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.

    Drug: Warfarin
    Other Names:
  • Marevan

    • Drug: Placebo (for Aspirin)
    Sugar pill manufactured to mimic 75 mg Aspirin

    Outcome Measures

    Primary Outcome Measures

    1. Valve Thrombosis [one year]

    Secondary Outcome Measures

    1. Major Systemic Embolism, [one year]

    2. Non-fatal intracranial hemorrhage [one year]

    3. Major extra cranial hemorrhage, [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University hospitals Cairo Egypt

    Sponsors and Collaborators

    • Pharmacoeconomic Unit, Egypt

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Gihan Hamdy Elsisi, Head of Pharmacoeconomic Unit, Pharmacoeconomic Unit, Egypt
    ClinicalTrials.gov Identifier:
    NCT02022527
    Other Study ID Numbers:
    • PEU2013
    First Posted:
    Dec 27, 2013
    Last Update Posted:
    Dec 30, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Gihan Hamdy Elsisi, Head of Pharmacoeconomic Unit, Pharmacoeconomic Unit, Egypt
    Cost-Effectiveness,
    Heart valve prosthesis
    Warfarin,
    Aspirin,
    Egypt
    Additional relevant MeSH terms:
    Aspirin
    Salicylic Acid
    Salicylates
    Warfarin

    Study Results

    No Results Posted as of Dec 30, 2013