Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis

NCT02022527 | Unknown Phase 4 DMC

• 1 other identifier: PEU2013
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications Due to Heart Valve Prosthesis

Keywords

Cost-Effectiveness,; Heart valve prosthesis; Warfarin,; Aspirin,; Egypt

Outcome Measures

Primary Outcomes (1)

• Valve Thrombosis

  one year

Secondary Outcomes (3)

• Major Systemic Embolism,

  one year

• Non-fatal intracranial hemorrhage

  one year

• Major extra cranial hemorrhage,

  one year

Study Arms (2)

Combination

EXPERIMENTAL

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; Drug: Warfarin

Warfarin

ACTIVE COMPARATOR

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; Drug: Placebo (for Aspirin)

Interventions

Acetyl Salicylic Acid DRUG

Also known as: Aspirin

Combination

Warfarin DRUG

Also known as: Marevan

Combination; Warfarin

Placebo (for Aspirin) DRUG

Sugar pill manufactured to mimic 75 mg Aspirin

Warfarin

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients operated in Ain Shams University Hospitals for aortic and/ or mitral valve replacement.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharmacoeconomic Unit, Egypt: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, Egypt

RECRUITING

Related Publications (1)

• Mohamed H. Antithrombotic therapy in patients with prosthetic heart valves. Libyan J Med. 2009 Mar 1;4(1):54-6. doi: 10.4176/090115.

  PMID: 21483507 BACKGROUND

MeSH Terms

Interventions

Aspirin; Warfarin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gihan H Elsisi, Msc

  Pharmacoeconomic Unit

  PRINCIPAL INVESTIGATOR

• Manal H Elhamamsy, PhD

  Faculty of pharmacy, Ain Shams University

  STUDY CHAIR

• Mohamed ME Mazar, PhD

  Central Administration for Pharmaceutical Affairs

  STUDY DIRECTOR

Central Study Contacts

Gihan H Elsisi, Msc

CONTACT

+201227366018; gihan-elsisi@hotmail.com

Manal H Elhamamsy, PhD

CONTACT

+201005257416; M_elhamamsy@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pharmacoeconomic Unit

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2014
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

EG (1)