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

P

Pharmacoeconomic Unit, Egypt

Status and phase

Unknown
Phase 4

Conditions

Complications Due to Heart Valve Prosthesis

Treatments

Drug: Warfarin
Drug: Acetyl Salicylic Acid
Drug: Placebo (for Aspirin)

Study type

Interventional

Funder types

Other

Identifiers

NCT02022527
PEU2013

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

15 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

300 participants in 2 patient groups

Combination
Experimental group
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.
Treatment:
Drug: Acetyl Salicylic Acid
Drug: Warfarin
Warfarin
Active Comparator group
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.
Treatment:
Drug: Placebo (for Aspirin)
Drug: Warfarin

Trial contacts and locations

1

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Central trial contact

Gihan H Elsisi, Msc; Manal H Elhamamsy, PhD

Data sourced from clinicaltrials.gov

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