Complications Due to Heart Valve ProsthesisPhase 4HVPNCT02022527
Cost Effectiveness Analysis In Patients With Heart Valve Prosthesis
A Phase 4 study testing Acetyl Salicylic Acid and Warfarin in people with Complications Due to Heart Valve Prosthesis, run by Pharmacoeconomic Unit, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Complications Due to Heart Valve Prosthesis
- What is being tested?
- Acetyl Salicylic Acid and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2013to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients operated in Ain Shams University Hospitals for aortic and/ or mitral valve replacement.
Who cannot join
- Congenital blood disorders, Hemophilia.
- Advanced liver disease
- Advanced renal disease (dialysis patients)
- Aspirin sensitivity
- Autoimmune diseases
- Biological bioprosthesis valves
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- Non-compliant \& Drop out patient
- Pregnant women
- Caucasians.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University hospitals
Cairo
Ahmed Hassouna, MD, +201223105271
Basma Awad, MD
About this study
Official title: Cost Effectiveness Analysis for Combination Of Aspirin And Warfarin Versus Warfarin Alone In Egyptian Patients With Heart Valve Prosthesis
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.
Read the detailed description
The measurements will be assessed:
A- Number of patients improved during follow up:
- Demographic data
- Diagnosis
- Laboratory tests (CBC, Prothrombin Time, liver and renal function tests)
- Echocardiography profile
B-Costs:
Direct medical costs will be assessed directly from hospital's records and tender lists.
- Being tested
- Acetyl Salicylic Acid, Warfarin, Placebo (for Aspirin)
- Keywords
- Cost-Effectiveness,, Heart valve prosthesis, Warfarin,, Aspirin,, Egypt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl Salicylic AcidDrug
Also called Aspirin
WarfarinDrug
Also called Marevan
Placebo (for Aspirin)Drug
Sugar pill manufactured to mimic 75 mg Aspirin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Warfarin; Drug: Placebo (for Aspirin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Valve Thrombosis
Measured: one year
Secondary outcomes (3)
Major Systemic Embolism,
Measured: one year
Non-fatal intracranial hemorrhage
Measured: one year
Major extra cranial hemorrhage,
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complications Due to Heart Valve ProsthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmacoeconomic Unit, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gihan Hamdy Elsisi, Pharmacoeconomic Unit, Egypt
- Investigators
- Gihan H Elsisi, Msc, Principal investigator, Pharmacoeconomic UnitManal H Elhamamsy, PhD, Study chair, Faculty of pharmacy, Ain Shams UniversityMohamed ME Mazar, PhD, Study director, Central Administration for Pharmaceutical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022527
- Sponsor's protocol ID
- PEU2013
- Acronym
- HVP
- Status last verified
- Dec 2013
- First submitted
- 20 Dec 2013
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mohamed H. Antithrombotic therapy in patients with prosthetic heart valves. Libyan J Med. 2009 Mar 1;4(1):54-6. doi: 10.4176/090115.
PubMed 21483507
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness Analysis for Combination Of Aspirin And Warfarin Versus Warfarin Alone In Egyptian Patients With Heart Valve Prosthesis
- ClinicalTrials.gov ID
- NCT02022527
- Acronym / sponsor ID
- HVP / PEU2013
- Keywords
- Cost-Effectiveness,, Heart valve prosthesis, Warfarin,, Aspirin,, Egypt
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Pharmacoeconomic Unit, EgyptOther government
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (estimated)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The measurements will be assessed:
A- Number of patients improved during follow up:
- Demographic data
- Diagnosis
- Laboratory tests (CBC, Prothrombin Time, liver and renal function tests)
- Echocardiography profile
B-Costs:
Direct medical costs will be assessed directly from hospital's records and tender lists.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination | Experimental | Drug: Acetyl Salicylic Acid, Drug: WarfarinWarfarin 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. |
| Warfarin | Active comparator | Drug: Warfarin, Drug: Placebo (for Aspirin)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. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients operated in Ain Shams University Hospitals for aortic and/ or mitral valve replacement.
Key exclusion criteria (9 listed)
- Congenital blood disorders, Hemophilia.
- Advanced liver disease
- Advanced renal disease (dialysis patients)
- Aspirin sensitivity
- Autoimmune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetyl Salicylic AcidAlso: Aspirin | Drug | Combination |
| WarfarinAlso: Marevan | Drug | Combination, Warfarin |
| Placebo (for Aspirin)Sugar pill manufactured to mimic 75 mg Aspirin | Drug | Warfarin |
Primary outcome
Valve Thrombosis
Time frame: one year
3 secondary outcomes
Major Systemic Embolism,
Time frame: one year
Non-fatal intracranial hemorrhage
Time frame: one year
Major extra cranial hemorrhage,
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2013.
- Background: PubMed 21483507Mohamed H. Antithrombotic therapy in patients with prosthetic heart valves. Libyan J Med. 2009 Mar 1;4(1):54-6. doi: 10.4176/090115.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gihan H Elsisi, Msc principal investigator
Pharmacoeconomic Unit
Manal H Elhamamsy, PhD study chair
Faculty of pharmacy, Ain Shams University
Mohamed ME Mazar, PhD study director
Central Administration for Pharmaceutical Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetyl Salicylic Acid and Warfarin in people with Complications Due to Heart Valve Prosthesis, run by Pharmacoeconomic Unit, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gihan H Elsisi, Msc (+201227366018, gihan-elsisi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Valve Thrombosis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02022527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2013.