Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT02022527
Status:
UNKNOWN
Last Update Posted:
2013-12-30
First Post:
2013-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2013-12-26', 'studyFirstSubmitDate': '2013-12-20', 'studyFirstSubmitQcDate': '2013-12-20', 'lastUpdatePostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Valve Thrombosis', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Major Systemic Embolism,', 'timeFrame': 'one year'}, {'measure': 'Non-fatal intracranial hemorrhage', 'timeFrame': 'one year'}, {'measure': 'Major extra cranial hemorrhage,', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cost-Effectiveness,', 'Heart valve prosthesis', 'Warfarin,', 'Aspirin,', 'Egypt'], 'conditions': ['Complications Due to Heart Valve Prosthesis']}, 'referencesModule': {'references': [{'pmid': '21483507', 'type': 'BACKGROUND', 'citation': 'Mohamed H. Antithrombotic therapy in patients with prosthetic heart valves. Libyan J Med. 2009 Mar 1;4(1):54-6. doi: 10.4176/090115.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "The measurements will be assessed:\n\nA- Number of patients improved during follow up:\n\n1. Demographic data\n2. Diagnosis\n3. Laboratory tests (CBC, Prothrombin Time, liver and renal function tests)\n4. Echocardiography profile\n\nB-Costs:\n\nDirect medical costs will be assessed directly from hospital's records and tender lists."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients operated in Ain Shams University Hospitals for aortic and/ or mitral valve replacement.\n\nExclusion Criteria:\n\n* Congenital blood disorders, Hemophilia.\n* Advanced liver disease\n* Advanced renal disease (dialysis patients)\n* Aspirin sensitivity\n* Autoimmune diseases\n* Biological bioprosthesis valves\n* Non-compliant \\& Drop out patient\n* Pregnant women\n* Caucasians.'}, 'identificationModule': {'nctId': 'NCT02022527', 'acronym': 'HVP', 'briefTitle': 'Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Pharmacoeconomic Unit, Egypt'}, 'officialTitle': 'Cost Effectiveness Analysis for Combination Of Aspirin And Warfarin Versus Warfarin Alone In Egyptian Patients With Heart Valve Prosthesis', 'orgStudyIdInfo': {'id': 'PEU2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination', 'description': '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.', 'interventionNames': ['Drug: Acetyl Salicylic Acid', 'Drug: Warfarin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Warfarin', 'description': '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.', 'interventionNames': ['Drug: Warfarin', 'Drug: Placebo (for Aspirin)']}], 'interventions': [{'name': 'Acetyl Salicylic Acid', 'type': 'DRUG', 'otherNames': ['Aspirin'], 'armGroupLabels': ['Combination']}, {'name': 'Warfarin', 'type': 'DRUG', 'otherNames': ['Marevan'], 'armGroupLabels': ['Combination', 'Warfarin']}, {'name': 'Placebo (for Aspirin)', 'type': 'DRUG', 'description': 'Sugar pill manufactured to mimic 75 mg Aspirin', 'armGroupLabels': ['Warfarin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Hassouna, MD', 'role': 'CONTACT', 'phone': '+201223105271'}, {'name': 'Basma Awad, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ain Shams University hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Gihan H Elsisi, Msc', 'role': 'CONTACT', 'email': 'gihan-elsisi@hotmail.com', 'phone': '+201227366018'}, {'name': 'Manal H Elhamamsy, PhD', 'role': 'CONTACT', 'email': 'M_elhamamsy@hotmail.com', 'phone': '+201005257416'}], 'overallOfficials': [{'name': 'Gihan H Elsisi, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pharmacoeconomic Unit'}, {'name': 'Manal H Elhamamsy, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of pharmacy, Ain Shams University'}, {'name': 'Mohamed ME Mazar, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Central Administration for Pharmaceutical Affairs'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmacoeconomic Unit, Egypt', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Pharmacoeconomic Unit', 'investigatorFullName': 'Gihan Hamdy Elsisi', 'investigatorAffiliation': 'Pharmacoeconomic Unit, Egypt'}}}}