Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis (HVP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Pharmacoeconomic Unit, Egypt
Sponsor:
Information provided by (Responsible Party):
Gihan Hamdy Elsisi, Pharmacoeconomic Unit, Egypt
ClinicalTrials.gov Identifier:
NCT02022527
First received: December 20, 2013
Last updated: December 26, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Complications Due to Heart Valve Prosthesis
Drug: Acetyl Salicylic Acid
Drug: Warfarin
Drug: Placebo (for Aspirin)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Cost Effectiveness Analysis for Combination Of Aspirin And Warfarin Versus Warfarin Alone In Egyptian Patients With Heart Valve Prosthesis

Resource links provided by NLM:


Further study details as provided by Pharmacoeconomic Unit, Egypt:

Primary Outcome Measures:
  • Valve Thrombosis [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major Systemic Embolism, [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Non-fatal intracranial hemorrhage [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Major extra cranial hemorrhage, [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: June 2013
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Aspirin
Drug: Warfarin
Other Name: 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 Name: Marevan
Drug: Placebo (for Aspirin)
Sugar pill manufactured to mimic 75 mg Aspirin

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.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022527

Contacts
Contact: Gihan H Elsisi, Msc +201227366018 gihan-elsisi@hotmail.com
Contact: Manal H Elhamamsy, PhD +201005257416 M_elhamamsy@hotmail.com

Locations
Egypt
Ain Shams University hospitals Recruiting
Cairo, Egypt
Contact: Ahmed Hassouna, MD    +201223105271      
Sub-Investigator: Basma Awad, MD         
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
  More Information

Additional Information:
Publications:
Responsible Party: Gihan Hamdy Elsisi, Head of Pharmacoeconomic Unit, Pharmacoeconomic Unit, Egypt
ClinicalTrials.gov Identifier: NCT02022527     History of Changes
Other Study ID Numbers: PEU2013
Study First Received: December 20, 2013
Last Updated: December 26, 2013
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Pharmacoeconomic Unit, Egypt:
Cost-Effectiveness,
Heart valve prosthesis
Warfarin,
Aspirin,
Egypt

Additional relevant MeSH terms:
Warfarin
Aspirin
Salicylic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Anticoagulants
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 16, 2014