This is a prospective comparison of pharmacist dosing and a pharmacogenetic algorithm in newly diagnosed patients requiring warfarin therapy. Newly diagnosed patients will be consented and a tube of blood for DNA analysis will be drawn. The pharmacist dosing group will not be eligible to see the pharmacogenetic results and the algorithm group will have their warfarin pharmacogenetic SNPs...
Date First Received: August 1, 2007
Last Updated: August 11, 2008
Verified by: Creighton University, August 2008
Clinical Trial Phase: Phase 4 | Start Date: August 2006
Overall Status: Recruiting
Estimated Enrollment: 250
Brief Summary
Official Title: “Warfarin Dosing: Pharmacogenetic Algorithm Compared to Pharmacist's Dosing”
Condition Keyword(s):
Intervention(s):
This is a prospective comparison of pharmacist dosing and a pharmacogenetic algorithm in newly diagnosed patients requiring warfarin therapy. Newly diagnosed patients will be consented and a tube of blood for DNA analysis will be drawn. The pharmacist dosing group will not be eligible to see the pharmacogenetic results and the algorithm group will have their warfarin pharmacogenetic SNPs performed and integrated into the algorithm and the warfarin dose will be calculated. Outcomes of patients receiving both methods will be gathered and statistically analyzed.
Study Type: Interventional
Study Design: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: June 2009
Intervention(s) in this Clinical Trial
- Genetic: Warfarin Dose adjustment
- Warfarin dose adjustment will be based on the standard pharmacist dosing compared to the use of the pharmacogenetic base algarithm
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 2
- Warfarin dose based on algorithm by Sconce, et al.
- Active Comparator: 1
- Warfarin dose based on pharmacist dosing
Outcome Measures for this Clinical Trial
Primary Measures
- To determine if the use of a pharmacogenetic algorithm improves the outcomes of patients using warfarin compared to conventional measures.
- Time Frame: six months
Safety Issue?: No
- Time Frame: six months
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Newly diagnosed patients requiring warfarin therapy
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 19 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Creighton University
Overall Clinical Trial Officials and Contacts
Christopher J. Destache, Pharm. D. Principal Investigator Creighton University
Overall Contact: Christopher J. Destache, Pharm. D. 402 280 4744 destache@creighton.edu
Additional Information
Information obtained from ClinicalTrials.gov on January 08, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00511173
Study ID Number: 06-14171
ClinicalTrials.gov Identifier: NCT00511173
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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