Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00313469
Status:
COMPLETED
Last Update Posted:
2011-08-25
First Post:
2006-04-10
Brief Title:
Sources of the Variability of the Response to Fluindione in Elderly Patients PREPA
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Sources of the Variability of the Response to Fluindione in Elderly Patients PREPA Etude Des Sources de variabilité de la réponse à la Fluindione Chez Les Personnes âgées de 80 Ans et Plus PREPA
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We propose to study the pharmacokinetic PK and pharmacodynamic PD components of the response to fluindione the main oral anticoagulant used in France in patients over 80
We expect to gain a better understanding of the role of age nutritional status genetic factors and drug interactions in the variability of the response to fluindione
We expect to gain a better understanding of the role of age nutritional status genetic factors and drug interactions in the variability of the response to fluindione
Detailed Description:
Oral anticoagulant drugs have improved the prognosis of patients with thromboembolic disease However optimal oral anticoagulation control is usually hampered by significant interindividual variability coupled with a narrow therapeutic window In the elderly this variability is enhanced by concurrent medications nutritional status and physical condition Age itself correlates with increased severity of complications and adverse events due to anticoagulant drug are thought to be responsible for up to 5000 deaths a year in France
Although half the patients receiving anticoagulant treatment are over 80 there has been only one study targeting this population so far We therefore propose to study the pharmacokinetic PK and pharmacodynamic PD components of the response to fluindione the main oral anticoagulant used in France in patients over 80
150 patients beginning fluindione treatment or resuming after 2 weeks rest will be recruited in the following departments Geriatric Cardiology Nephrology Cardiac Surgery Internal Medicine CHU Bichat-Claude Bernard Paris and Metabolic Diseases and Internal Medicine CHU dAngers Blood sampling will take place before the beginning of the study J0 to measure baseline INR and coagulation factors II and VII Fluindione concentrations will also be measured in non-naive patients INR coagulation factors and fluindione will be measured at J2 J4 J6 J8 and twice weekly until they leave the hospital or up to a month Many covariates will be recorded age gender concurrent medications biochemical analyses functional and nutritional status We will also investigate genetic factors by collecting DNA to genotype polymorphisms related to the target of the drug Recent work has shown that both the response to common anticoagulant drugs and their metabolism was influenced by genetic polymorphisms and there is now convincing evidence that drug targets are controlled by genetic polymorphisms which can play a major role in the variability of the response
Throughout the study the physicians remain free to adapt drug regimen and prescribe additional INR measurements
Data analysis will be performed in INSERM Unit 738 CHU Bichat-Claude Bernard using nonlinear mixed-effect models statistical techniques allowing the analysis of sparse data while quantifying the sources of variability
We expect to gain a better understanding of the role of age nutritional status genetic factors and drug interactions in the variability of the response to fluindione We will also assess whether measuring the activity of coagulation factors helps to anticipate dangerous increases in INR These goals are vital to provide better care of the elderly and minimise costs arising from the frequency of severe side-effects
Future perspectives include the development of a software and recommendations to help adapt anticoagulant treatment in the elderly taking into account their condition
Although half the patients receiving anticoagulant treatment are over 80 there has been only one study targeting this population so far We therefore propose to study the pharmacokinetic PK and pharmacodynamic PD components of the response to fluindione the main oral anticoagulant used in France in patients over 80
150 patients beginning fluindione treatment or resuming after 2 weeks rest will be recruited in the following departments Geriatric Cardiology Nephrology Cardiac Surgery Internal Medicine CHU Bichat-Claude Bernard Paris and Metabolic Diseases and Internal Medicine CHU dAngers Blood sampling will take place before the beginning of the study J0 to measure baseline INR and coagulation factors II and VII Fluindione concentrations will also be measured in non-naive patients INR coagulation factors and fluindione will be measured at J2 J4 J6 J8 and twice weekly until they leave the hospital or up to a month Many covariates will be recorded age gender concurrent medications biochemical analyses functional and nutritional status We will also investigate genetic factors by collecting DNA to genotype polymorphisms related to the target of the drug Recent work has shown that both the response to common anticoagulant drugs and their metabolism was influenced by genetic polymorphisms and there is now convincing evidence that drug targets are controlled by genetic polymorphisms which can play a major role in the variability of the response
Throughout the study the physicians remain free to adapt drug regimen and prescribe additional INR measurements
Data analysis will be performed in INSERM Unit 738 CHU Bichat-Claude Bernard using nonlinear mixed-effect models statistical techniques allowing the analysis of sparse data while quantifying the sources of variability
We expect to gain a better understanding of the role of age nutritional status genetic factors and drug interactions in the variability of the response to fluindione We will also assess whether measuring the activity of coagulation factors helps to anticipate dangerous increases in INR These goals are vital to provide better care of the elderly and minimise costs arising from the frequency of severe side-effects
Future perspectives include the development of a software and recommendations to help adapt anticoagulant treatment in the elderly taking into account their condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GIS Institut Longévité 2003 | None | None | None |