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Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis

NCT02022527 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2013-12-30

No results posted yet for this study

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.

Conditions

  • Complications Due to Heart Valve Prosthesis

Interventions

DRUG

Acetyl Salicylic Acid

DRUG

Warfarin

DRUG

Placebo (for Aspirin)

Sugar pill manufactured to mimic 75 mg Aspirin

Sponsors & Collaborators

  • Pharmacoeconomic Unit, Egypt

    lead OTHER_GOV

Principal Investigators

  • Gihan H Elsisi, Msc · Pharmacoeconomic Unit

  • Manal H Elhamamsy, PhD · Faculty of pharmacy, Ain Shams University

  • Mohamed ME Mazar, PhD · Central Administration for Pharmaceutical Affairs

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02022527 on ClinicalTrials.gov