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Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis

NCT ID: NCT02022527

Last Updated: 2013-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Complications Due to Heart Valve Prosthesis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Acetyl Salicylic Acid

Intervention Type DRUG

Warfarin

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Placebo (for Aspirin)

Intervention Type DRUG

Sugar pill manufactured to mimic 75 mg Aspirin

Interventions

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Acetyl Salicylic Acid

Intervention Type DRUG

Warfarin

Intervention Type DRUG

Placebo (for Aspirin)

Sugar pill manufactured to mimic 75 mg Aspirin

Intervention Type DRUG

Other Intervention Names

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Aspirin Marevan

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmacoeconomic Unit, Egypt

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gihan Hamdy Elsisi

Head of Pharmacoeconomic Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gihan H Elsisi, Msc

Role: PRINCIPAL_INVESTIGATOR

Pharmacoeconomic Unit

Manal H Elhamamsy, PhD

Role: STUDY_CHAIR

Faculty of pharmacy, Ain Shams University

Mohamed ME Mazar, PhD

Role: STUDY_DIRECTOR

Central Administration for Pharmaceutical Affairs

Locations

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Ain Shams University hospitals

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Gihan H Elsisi, Msc

Role: CONTACT

Phone: +201227366018

Email: [email protected]

Manal H Elhamamsy, PhD

Role: CONTACT

Phone: +201005257416

Email: [email protected]

Facility Contacts

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Ahmed Hassouna, MD

Role: primary

References

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

Reference Type BACKGROUND
PMID: 21483507 (View on PubMed)

Other Identifiers

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PEU2013

Identifier Type: -

Identifier Source: org_study_id