Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334464
Status:
COMPLETED
Last Update Posted:
2008-08-21
First Post:
2006-06-05
Brief Title:
A Pharmacogenetic Study of Warfarin Dosing The COUMA-GEN Study
Sponsor:
Intermountain Health Care Inc
Organization:
Intermountain Health Care Inc
Study Overview
Official Title:
A Controlled Clinical Pharmacogenetic Study of a CYP2C9 Plus VKORC1 Polymorphism-Based Individualized Dosing Algorithm for Warfarin to Increase Efficiency of Achieving Therapeutic Dosing
Status:
COMPLETED
Status Verified Date:
2008-08
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:
Anticoagulation with warfarin is a common and potentially hazardous therapeutic intervention It is a leading cause of iatrogenic bleeding events and hence of malpractice claims There are no good alternatives presently for warfarin anticoagulation and even when alternatives become available ie ximelagatran cost labeling and experience outcomes-related issues will continue to favor an extensive and ongoing use of warfarin If the present study is able to confirm an advantage for a genotype-driven algorithm in terms of improved efficiency therapeutic efficacy and especially safety then a pharmacogenetics approach to warfarin dosing can be recommended as the basis for an Intermountain Health Care IHC-wide quality improvement initiative that should improve patient outcomes reduce resource use costs of achieving safe and therapeutic anticoagulation and reduce adverse clinical events COUMA-GEN is a prospective randomized study of patients who are to begin chronic warfarin therapy for specific qualifying clinical reasons ie atrial fibrillation AF deep vein thrombosis DVT or post-orthopedic surgery prophylaxis Qualifying patients will be consented and randomized to an individualized genotype-based warfarin-dosing regimen or to standard care without knowledge of genotype In each study arm a predicted maintenance dose will be determined All patients will receive a baseline International Normalized Ratio INR For patients in all 3 entry strata a starting dose of warfarin that is twice the assigned daily maintenance dose according to the specific treatment arm will be prescribed on the first and second days and then the dose will revert to the assigned maintenance dose
Detailed Description:
The objectives of this study are to determine
1 whether the pharmacogenetic guided arm can maintain patients a greater time in therapeutic range TTR - percentage of values in the targeted therapeutic range once a therapeutic INR has been established without clinical adverse events ie bleeding complications or thromboembolic events
2 whether the pharmacogenetic guided arm can achieve a higher percentage of therapeutic warfarin levels by days 5 and 8 of therapy without intervening non-study dose adjustment and
3 whether the pharmacogenetic guided arm can reduce the need for unplanned dose adjustments and additional INR measurements because of excessive or insufficient INR level and clinical adverse events ie bleeding complications or thromboembolic events
The goal is to achieve 75 TTR in the PG-algorithm arm Compare proportion of patients reaching therapeutic INR on days 5 and 8 and the subsequent and overall proportion time of INR measurements in therapeutic range TTR over 3 months between standard and PG-based arms
This study will enroll 200 qualifying consenting patients of either gender 18 years and above any ethnicity with life expectancies 1 year beginning on chronic outpatient warfarin therapy for AF or emergency departmentoutpatient therapy for spontaneous DVT or inpatient therapy and continued for 1 mo after orthopedic surgery for DVT prevention or heart failure patients EF25 or apical akinesis or left ventricular aneurysm or extensive wall motion abnormality being started on therapy to reduce the risk of thromboembolism
1 whether the pharmacogenetic guided arm can maintain patients a greater time in therapeutic range TTR - percentage of values in the targeted therapeutic range once a therapeutic INR has been established without clinical adverse events ie bleeding complications or thromboembolic events
2 whether the pharmacogenetic guided arm can achieve a higher percentage of therapeutic warfarin levels by days 5 and 8 of therapy without intervening non-study dose adjustment and
3 whether the pharmacogenetic guided arm can reduce the need for unplanned dose adjustments and additional INR measurements because of excessive or insufficient INR level and clinical adverse events ie bleeding complications or thromboembolic events
The goal is to achieve 75 TTR in the PG-algorithm arm Compare proportion of patients reaching therapeutic INR on days 5 and 8 and the subsequent and overall proportion time of INR measurements in therapeutic range TTR over 3 months between standard and PG-based arms
This study will enroll 200 qualifying consenting patients of either gender 18 years and above any ethnicity with life expectancies 1 year beginning on chronic outpatient warfarin therapy for AF or emergency departmentoutpatient therapy for spontaneous DVT or inpatient therapy and continued for 1 mo after orthopedic surgery for DVT prevention or heart failure patients EF25 or apical akinesis or left ventricular aneurysm or extensive wall motion abnormality being started on therapy to reduce the risk of thromboembolism
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