Ignite Creation Date:
2024-05-05 @ 9:35 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00927862
Status:
COMPLETED
Last Update Posted:
2012-09-25
First Post:
2009-06-23
Brief Title:
Applying Pharmacogenetic Algorithms to Individualize Dosing of Warfarin
Sponsor:
Intermountain Health Care Inc
Organization:
Intermountain Health Care Inc
Study Overview
Official Title:
The Clinical Impact of Applying Pharmacogenetic Algorithms to Individualize Dosing of Warfarin in Patients Being Initiated on Oral Anticoagulation
Status:
COMPLETED
Status Verified Date:
2012-08
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:
Coumagen-II
Brief Summary:
The purpose of this study is to determine whether DNA analysis improves the efficiency of dosing and safety in patients who are being started on warfarin therapyWarfarin a blood thinner anticoagulant prescribed to 1-2 million patients in the United States is a leading cause of drug-related adverse events eg severe bleeding in large part due to dramatic 20-fold differences between individuals in dose requirements At least half of this variability now can be explained by 3 common genetic variants age body size and sex however warfarin therapy continues to begin with the same dose in every patient with the correct individual dose determined by trial and error This study proposes to determine genetic variations the same day from DNA simply obtained by swabbing the inside of the cheek and use this information to determine the proper dose regimen individually in each patient The aim is to show that the investigators can achieve more rapid efficient and safe dosing in up to 500-1000 individuals who are initiating warfarin therapy for various clotting disorders across a large healthcare system in order to demonstrate improved dosing effectiveness efficiency and safety with genetic-based dosing which could lead to a nationwide application resulting in as much as a 1 billion dollar annual benefit in healthcare outcomes
Detailed Description:
Study Objectives
The specific objectives of CoumaGen-II to be tested are
1 To apply routine pharmacogenetic PG-guided dosing of warfarin in clinical practice at Intermountain Healthcare facilities in the Urban Central Region ie Intermountain Medical Center IMC LDS Hospital Alta View Hospital AVH and selected physician offices that are frequent initiators of warfarin in a major new quality improvement and clinical research initiative
2 To compare the percentage out-of-range OOR international normalized prothrombin time ratios INRs during the first month and secondarily 3 months of warfarin therapy using PG-guided dosing with parallel or historical standard STD empiric dosed controls
3 To compare a modified PG-guided dosing algorithm modified-International Warfarin Pharmacogenetics Consortium IWPC with a previously generated and validated multicenter PG-guided algorithm IWPC
Study Design
Qualifying patients being initiated on warfarin therapy with a target INR of 15-25 2-3 or 25-35 will be invited to participate and sign informed consent Enrolled patients will receive DNA sampling by buccal swab and samples will be processed and a PG-guided initial dose calculated with a goal of 6 hours maximum 24 hours Dosing and dose adjustments will be managed through the Urban Central Region IMCLDSH anticoagulation management service AMS Dose adjustments through day 8 will use a PG-modified algorithm after which modification will revert to the standard IHC algorithm AMS pharmacists and study coordinators will ascertain warfarin doses INRs dose changes and adverse events and record information on case report forms
Study Duration
Each patient will participate for approximately 3 months 90 days 10 days The anticipated enrollment period is 24 months or until 1000 patients are enrolled The length of the enrollment period is subject to revision as it is dependent on the availability of a robust patient pool
Further study details on dosing algorithm and genotyping methodology may be provided by Intermountain Healthcare Inc
The specific objectives of CoumaGen-II to be tested are
1 To apply routine pharmacogenetic PG-guided dosing of warfarin in clinical practice at Intermountain Healthcare facilities in the Urban Central Region ie Intermountain Medical Center IMC LDS Hospital Alta View Hospital AVH and selected physician offices that are frequent initiators of warfarin in a major new quality improvement and clinical research initiative
2 To compare the percentage out-of-range OOR international normalized prothrombin time ratios INRs during the first month and secondarily 3 months of warfarin therapy using PG-guided dosing with parallel or historical standard STD empiric dosed controls
3 To compare a modified PG-guided dosing algorithm modified-International Warfarin Pharmacogenetics Consortium IWPC with a previously generated and validated multicenter PG-guided algorithm IWPC
Study Design
Qualifying patients being initiated on warfarin therapy with a target INR of 15-25 2-3 or 25-35 will be invited to participate and sign informed consent Enrolled patients will receive DNA sampling by buccal swab and samples will be processed and a PG-guided initial dose calculated with a goal of 6 hours maximum 24 hours Dosing and dose adjustments will be managed through the Urban Central Region IMCLDSH anticoagulation management service AMS Dose adjustments through day 8 will use a PG-modified algorithm after which modification will revert to the standard IHC algorithm AMS pharmacists and study coordinators will ascertain warfarin doses INRs dose changes and adverse events and record information on case report forms
Study Duration
Each patient will participate for approximately 3 months 90 days 10 days The anticipated enrollment period is 24 months or until 1000 patients are enrolled The length of the enrollment period is subject to revision as it is dependent on the availability of a robust patient pool
Further study details on dosing algorithm and genotyping methodology may be provided by Intermountain Healthcare Inc
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