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NCT00927862 · ClinicalTrials.gov registry record · Phase 2
Applying Pharmacogenetic Algorithms to Individualize Dosing of Warfarin
A Phase 2 study, sponsored by Intermountain Health Care.
- Completed
- Registry status
- Phase 2
- Development phase
- 2,415
- Enrollment target
NCT00927862: Completed Phase 2 study, sponsored by Intermountain Health Care.
NCT00927862 is a Phase 2 study that has completed, run by Intermountain Health Care. The registered enrollment target is 2,415 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1716% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00927862, a Phase 2 study, has completed, sponsored by Intermountain Health Care.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2,415 participants
- Enrollment target
Study 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 therapy.Warfarin, a blood thinner (anticoagulant) prescribed to 1-2 million patients in the United States, is a leading cause of drug-related adverse events (e.g., 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.
Primary Outcome
The percent of out of range (OOR) international normalized prothrombin time ratio (INRs) in the standard and modified pharmacogentic algorithms at 1 month. To account for laboratory INR-measurement error, a 10% margin outside of the target range was allowed in determination of OOR values, ie, INRs \<1.8, \>3.3 for INR 2.5 target; \<2.25, \>3.85 for INR 3.0 target. What is reported is the percent of patients with an OOR INR at 1 month.
Interventions
- OTHER Standard of care treatment
- GENETIC IWPC adapted genotype-guided dosing algorithm for warfarin
- GENETIC Modified IWPC genetic-guided warfarin dosing algorithm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,415 participants |
| Start Date | 2008-08 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT00927862 record still lists
NCT00927862 is an interventional study that assigns participants to a tested intervention. Its 2,415 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1716% higher).
The record links to 0 conditions, and to 3 interventions - of which Standard of care treatment is the first listed.
NCT00927862 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00927862 about?
NCT00927862 is a clinical study titled "Applying Pharmacogenetic Algorithms to Individualize Dosing of Warfarin". 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 therapy.Warfarin, a blood thinner (anticoagulant) prescribed to 1-2 million patients in the United States, is a leading cause of drug-related adve...
What is the current status of trial NCT00927862?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,415 participants. The study started on 2008-08. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00927862?
The interventions under investigation include: Standard of care treatment (OTHER), IWPC adapted genotype-guided dosing algorithm for warfarin (GENETIC), Modified IWPC genetic-guided warfarin dosing algorithm (GENETIC).
Who is sponsoring clinical trial NCT00927862?
This trial is sponsored by Intermountain Health Care, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00927862's enrollment target sits among peer trials
2,415 8th of 2000 higher than 1,993 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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