Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484640
Status:
UNKNOWN
Last Update Posted:
2007-06-11
First Post:
2007-06-04
Brief Title:
Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing
Sponsor:
Agency for Healthcare Research and Quality AHRQ
Organization:
Agency for Healthcare Research and Quality AHRQ
Study Overview
Official Title:
Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
NOT_YET_RECRUITING
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:
The study goal is to conduct a randomized controlled trial to compare safety and accuracy of dosing based on clinical information including the clinical reason for your taking coumadin your age gender your body surface area and other medical conditions you may have with dosing estimated by a dosing calculator which adjusts for factors affecting coumadin dosing variability including genotypes for genes important in Coumadin metabolism and response The hypothesis to be tested by this trial states thatwhen compared to patients managed with a best practices standard-of-care coumadin dosing regimen patients randomized to coumadin dosing based on genetically programmed metabolic capacity and other known clinical and environmental factors affecting dose will 1show reduced risk of adverse events using surrogate measures of such events and 2more rapidly achieve Coumadin dosing
Detailed Description:
The study goal is to conduct a randomized controlled trial to compare safety and accuracy of dosing based on clinical information including clinical reason for taking coumadin your age gender your body surface area and other medical conditions you may have and dosing with dosing estimated by a dosing calculator which adjusts for factors affecting coumadin dosing variability including genotypes for genes important in Coumadin metabolism and response The hypothesis to be tested by this trial states thatwhen compared to patients managed with a best practices standard-of-care coumadin dosing regimen patients randomized to coumadin dosing based on genetically programmed metabolic capacity and other known clinical and environmental factors affecting dose will 1show reduced risk of adverse events using surrogate measures of such events and 2more rapidly achieve Coumadin dosing
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