Ignite Creation Date:
2024-05-05 @ 10:27 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01119274
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2010-05-04
Brief Title:
EUropean Pharmacogenetics of AntiCoagulant Therapy - Phenprocoumon
Sponsor:
Utrecht Institute for Pharmaceutical Sciences
Organization:
Utrecht Institute for Pharmaceutical Sciences
Study Overview
Official Title:
EUropean Pharmacogenetics of AntiCoagulant Therapy - Phenprocoumon
Status:
COMPLETED
Status Verified Date:
2013-06
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:
EU-PACT
Brief Summary:
Rationale
The narrow therapeutic range and wide inter-patient variability in dose requirement make anticoagulation response to coumarin derivatives unpredictable As a result patients require frequent monitoring to avert adverse effects and maintain therapeutic efficacy Polymorphisms in cytochrome P450 2C9 CYP2C9 and vitamin K epoxide reductase complex 1 VKORC1 jointly account for about 40 of the inter-individual variability in dose requirements To date several pharmacogenetic guided dosing algorithms for coumarin derivatives predominately for warfarin have been developed However the potential benefit of these dosing algorithms in terms of their safety and clinical utility has not been adequately investigated in randomised settings
Objective
To determine whether a dosing algorithm containing genetic information increases the time within therapeutic INR range during anticoagulation therapy with each of warfarin acenocoumarol and phenprocoumon compared to a dosing regimen that does not contain this information Secondary outcomes of the study include cost effectiveness number of thromboembolic and bleeding events time to reach stable dose and number of supratherapeutic INR peaks
Study design
This is a two-armed single-blinded randomised controlled trial In one arm intervention patients commencing anticoagulation therapy with either warfarin acenocoumarol or phenprocoumon will be dosed according to a drug-specific genotype-guided dosing algorithm which is based on genetic information clinical data and in the monitoring phase previous INR For the other arm control patients will be dosed according to a non-genotype-guided dosing regimen which does not include genetic information The follow-up period per patient is 3 months
Study population
Newly diagnosed patients of both genders and at least 18 years old who need anticoagulant treatment with either acenocoumarol phenprocoumon or warfarin within the low intensity INR range will be included in the trial Main study parametersendpoints The time within therapeutic INR range in the first 3 months of anticoagulation therapy Nature and extent of the burden and risks associated with participation benefit and group relatedness Six extra blood samples are taken from each participant at the start of the study Patients also have to attend 8 scheduled visits within the 3 months study period and are asked to fill in questionnaires The genotype-guided dosing algorithm is anticipated to improve the accuracy of coumarin dosing and thus improve the safety and efficacy of anticoagulation therapy
The narrow therapeutic range and wide inter-patient variability in dose requirement make anticoagulation response to coumarin derivatives unpredictable As a result patients require frequent monitoring to avert adverse effects and maintain therapeutic efficacy Polymorphisms in cytochrome P450 2C9 CYP2C9 and vitamin K epoxide reductase complex 1 VKORC1 jointly account for about 40 of the inter-individual variability in dose requirements To date several pharmacogenetic guided dosing algorithms for coumarin derivatives predominately for warfarin have been developed However the potential benefit of these dosing algorithms in terms of their safety and clinical utility has not been adequately investigated in randomised settings
Objective
To determine whether a dosing algorithm containing genetic information increases the time within therapeutic INR range during anticoagulation therapy with each of warfarin acenocoumarol and phenprocoumon compared to a dosing regimen that does not contain this information Secondary outcomes of the study include cost effectiveness number of thromboembolic and bleeding events time to reach stable dose and number of supratherapeutic INR peaks
Study design
This is a two-armed single-blinded randomised controlled trial In one arm intervention patients commencing anticoagulation therapy with either warfarin acenocoumarol or phenprocoumon will be dosed according to a drug-specific genotype-guided dosing algorithm which is based on genetic information clinical data and in the monitoring phase previous INR For the other arm control patients will be dosed according to a non-genotype-guided dosing regimen which does not include genetic information The follow-up period per patient is 3 months
Study population
Newly diagnosed patients of both genders and at least 18 years old who need anticoagulant treatment with either acenocoumarol phenprocoumon or warfarin within the low intensity INR range will be included in the trial Main study parametersendpoints The time within therapeutic INR range in the first 3 months of anticoagulation therapy Nature and extent of the burden and risks associated with participation benefit and group relatedness Six extra blood samples are taken from each participant at the start of the study Patients also have to attend 8 scheduled visits within the 3 months study period and are asked to fill in questionnaires The genotype-guided dosing algorithm is anticipated to improve the accuracy of coumarin dosing and thus improve the safety and efficacy of anticoagulation therapy
Detailed Description:
None
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 |
|---|---|---|---|
| 2009-016994-13 | EUDRACT_NUMBER | European Union - Seventh Framework Programme | None |
| 223062 | OTHER_GRANT | None | None |