Poor Drug ResponseNCT03485300
The Prevalence of Sub Optimal Anti Coagulation
An observational study of Poor Drug Response, run by Assiut University.
Trial summary
A study on warfarin administration to show whether noncompliance of the patient will affect our target (INR) during therapy or not beside its drug and dietary interactions. The study will show the prevalence of sub optimal anti coagulation among patients with prosthetic cardiac valves that will undergo warfarin… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Poor Drug Response
- What is being tested?
- Liver and kidney function tests for patients with chronic liver or kidney diseases, Non compliance of the patient and Drug or food interactions
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Dec 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with valvular heart diseases undergoing prosthetic cardiac valves surgeries and on warfarin treatment that will come to outpatients clinics for regular follow up in either Assuit University Hospital or Assuit Police Hospital
Who may be able to join
- All patients of prosthetic cardiac valves undergo warfarin therapy with sub optimal anti coagulation
Who cannot join
- Refusal of the patients
- Patients with target INR (2.5-3.5)
- Patients with hypoalbumenimia and chronic liver diseases
Trial locations and contacts
No sites are listed yet.
Ahmed Ali Obiedallah an assistant professor at internal medicine department, MD contact
About this study
Official title: Prevalence of Sub Optimal Anti Coagulation in Patients With Prosthetic Cardiac Valves
A study on warfarin administration to show whether noncompliance of the patient will affect our target (INR) during therapy or not beside its drug and dietary interactions.
The study will show the prevalence of sub optimal anti coagulation among patients with prosthetic cardiac valves that will undergo warfarin therapy.
Read the detailed description
Besides the risk of infective endocarditis, thromboembolism from the foreign body structures of the prosthesis remains a major problem, which can be effectively reduced, but not inhibited by the use of oral anticoagulants in patients with prosthetic cardiac valves.
Warfarin as a vitamin k antagonist is widely used to decrease risk of thromboembolism but need strict monitoring for INR to avoid warfarin failure or hemorrhage.
It acts through inhibiting an enzyme called the vitamin K1 2,3 epoxide reductase complex, subunit1 (VKORC1).
All patients with mechanical heart valves need the oral anticoagulation to keep the INR between 2.5:3.5 according to valve type, position and other comorbid conditions.
However some patients need higher than expected doses of warfarin to get their (INR) into the target therapeutic range.
Resistance to warfarin has been described as the inability to prolong the prothrombin time or raise the international normalized ratio (INR) into the therapeutic range when the drug is given at normally prescribed doses.
Resistance is different than warfarin failure ,which is defined as a new thrombotic event despite a therapeutic prothrombin time and INR .
The causes of warfarin resistance can be either acquired from high consumption of vitamin K or C ,decreased absorption or increased clearance of the drug ,dietary or drug interactions or hereditary by genetic factors that result either in faster metabolism of the drug (a form of pharmacokinetic resistance) or in lower activity of the drug (pharmacodynamic resistance).
- Conditions
- Poor Drug Response
- Being tested
- Liver and kidney function tests for patients with chronic liver or kidney diseases, Non compliance of the patient, Drug or food interactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver and kidney function tests for patients with chronic liver or kidney diseasesDiagnostic test
Also called SGOT - SGPT - albumin, creatinine - urea
Tests will be done to patients with history suggestive of chronic liver or renal diseases or for patients clinically suspected
Non compliance of the patientBehavioural
Also called Asking patient about daily intake of the drug in certain time
I will order all my patients to take the drug at 10 am and assure the daily in taking of the dose and they will be followed up
Drug or food interactionsDrug
Also called Checking other drugs may be added with warfarin and dietary habits
The patient will be in contact with the researcher for any drug added with warfarin in case of other co morbidity conditions and follow up his/her CBC and INR for measuring its effect on warfarin finding out the effect of food on warfarin therapeutic outcome
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic liver or kidney diseases | Patients with chronic liver diseases may affect warfarin therapeutic outcome as liver is the site of metabolism of the drug by cytochrome p 450 enzymes so it decrease warfarin absorption
Kidney diseases also affect the clearance of the drug these patients will undergo liver function tests and kidney function tests Receives: Diagnostic Test: Liver and kidney function tests for patients with chronic liver or kidney diseases | |
| Non compliance of the patient | Missed dose of the warfarin or intermittent drug intake may affect drug therapeutic outcome as well as changing time of drug administration during the day Receives: Behavioral: Non compliance of the patient | |
| Drugs or food interactions | Administration of other drugs beside warfarin may affect its therapeutic outcome either by inhibition or synergism certain food may also interfere with warfarin especially vitamin k and c rich food so patients will be followed up for drug or food interactions Receives: Drug: Drug or food interactions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the prevalence of sub optimal anti coagulation in patients with prosthetic cardiac valves
Warfarin therapy is needed in patients with prosthetic cardiac valves to obtain the target INR from 2.5-3.5 .
If some patients with prosthetic cardiac valves have sub optimal anti coagulation with INR less than 2.5 with maximal doses of warfarin the research will measure their prevalence in all patients with prosthetic cardiac valves on warfarin therapy and their will be questionnaire for some causes of sub optimal anti coagulation in those patients.
The research will fulfill the following questionnaire :
Does the patient compliance play a role in warfarin therapeutic outcome? Does changing the time of warfarin administration during the day affect its therapeutic outcome? Does administration of other medication with warfarin including contraception affect its therapeutic outcome? Does dietary habits of certain foods during warfarin administration affect its therapeutic outcome?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study startDec 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Drug ResponseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Sobhy Gerges, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485300
- Sponsor's protocol ID
- Sub optimal anti coagulation
- Status last verified
- Jul 2018
- First submitted
- 27 Mar 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sub Optimal Anti Coagulation in Patients With Prosthetic Cardiac Valves
- ClinicalTrials.gov ID
- NCT03485300
- Acronym / sponsor ID
- Sub optimal anti coagulation
- Conditions
- Poor Drug Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Apr 2018 (actual)
- 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.
A study on warfarin administration to show whether noncompliance of the patient will affect our target (INR) during therapy or not beside its drug and dietary interactions.
The study will show the prevalence of sub optimal anti coagulation among patients with prosthetic cardiac valves that will undergo warfarin therapy.
Detailed description
Besides the risk of infective endocarditis, thromboembolism from the foreign body structures of the prosthesis remains a major problem, which can be effectively reduced, but not inhibited by the use of oral anticoagulants in patients with prosthetic cardiac valves.
Warfarin as a vitamin k antagonist is widely used to decrease risk of thromboembolism but need strict monitoring for INR to avoid warfarin failure or hemorrhage.
It acts through inhibiting an enzyme called the vitamin K1 2,3 epoxide reductase complex, subunit1 (VKORC1).
All patients with mechanical heart valves need the oral anticoagulation to keep the INR between 2.5:3.5 according to valve type, position and other comorbid conditions.
However some patients need higher than expected doses of warfarin to get their (INR) into the target therapeutic range.
Resistance to warfarin has been described as the inability to prolong the prothrombin time or raise the international normalized ratio (INR) into the therapeutic range when the drug is given at normally prescribed doses.
Resistance is different than warfarin failure ,which is defined as a new thrombotic event despite a therapeutic prothrombin time and INR .
The causes of warfarin resistance can be either acquired from high consumption of vitamin K or C ,decreased absorption or increased clearance of the drug ,dietary or drug interactions or hereditary by genetic factors that result either in faster metabolism of the drug (a form of pharmacokinetic resistance) or in lower activity of the drug (pharmacodynamic resistance).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic liver or kidney diseases | – | Diagnostic Test: Liver and kidney function tests for patients with chronic liver or kidney diseasesPatients with chronic liver diseases may affect warfarin therapeutic outcome as liver is the site of metabolism of the drug by cytochrome p 450 enzymes so it decrease warfarin absorption Kidney diseases also affect the clearance of the drug these patients will undergo liver function tests and kidney function tests |
| Non compliance of the patient | – | Behavioral: Non compliance of the patientMissed dose of the warfarin or intermittent drug intake may affect drug therapeutic outcome as well as changing time of drug administration during the day |
| Drugs or food interactions | – | Drug: Drug or food interactionsAdministration of other drugs beside warfarin may affect its therapeutic outcome either by inhibition or synergism certain food may also interfere with warfarin especially vitamin k and c rich food so patients will be followed up for drug or food interactions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with valvular heart diseases undergoing prosthetic cardiac valves surgeries and on warfarin treatment that will come to outpatients clinics for regular follow up in either Assuit University Hospital or Assuit Police Hospital
Key inclusion criteria (1 listed)
- All patients of prosthetic cardiac valves undergo warfarin therapy with sub optimal anti coagulation
Key exclusion criteria (3 listed)
- Refusal of the patients
- Patients with target INR (2.5-3.5)
- Patients with hypoalbumenimia and chronic liver 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 |
|---|---|---|
| Liver and kidney function tests for patients with chronic liver or kidney diseasesAlso: SGOT - SGPT - albumin, creatinine - ureaTests will be done to patients with history suggestive of chronic liver or renal diseases or for patients clinically suspected | Diagnostic test | Patients with chronic liver or kidney diseases |
| Non compliance of the patientAlso: Asking patient about daily intake of the drug in certain timeI will order all my patients to take the drug at 10 am and assure the daily in taking of the dose and they will be followed up | Behavioural | Non compliance of the patient |
| Drug or food interactionsAlso: Checking other drugs may be added with warfarin and dietary habitsThe patient will be in contact with the researcher for any drug added with warfarin in case of other co morbidity conditions and follow up his/her CBC and INR for measuring its effect on warfarin finding out the effect of food on warfarin therapeutic outcome | Drug | Drugs or food interactions |
Primary outcome
Measurement of the prevalence of sub optimal anti coagulation in patients with prosthetic cardiac valves
Time frame: 1 year
Warfarin therapy is needed in patients with prosthetic cardiac valves to obtain the target INR from 2.5-3.5 . If some patients with prosthetic cardiac valves have sub optimal anti coagulation with INR less than 2.5 with maximal doses of warfarin the research will measure their prevalence in all patients with prosthetic cardiac valves on warfarin therapy and their will be questionnaire for some causes of sub optimal anti coagulation in those patients. The research will fulfill the following questionnaire : Does the patient compliance play a role in warfarin therapeutic outcome? Does changing the time of warfarin administration during the day affect its therapeutic outcome? Does administration of other medication with warfarin including contraception affect its therapeutic outcome? Does dietary habits of certain foods during warfarin administration affect its therapeutic outcome?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Management of Supratherapeutic International Normalized Ratio without Bleeding after Warfarin UseLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Recruiting
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Premature Ovarian Insufficiency, Intrauterine Adhesion
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.
Ahmed Ali Obiedallah an assistant professor at internal medicine department, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Poor Drug Response, run by Assiut University.
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 3 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 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Ahmed Ali Obiedallah an assistant professor at internal medicine department, MD (01007556396, maruim_rose@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the prevalence of sub optimal anti coagulation in patients with prosthetic cardiac valves (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2018.