Trial · NCT00927862
Applying Pharmacogenetic Algorithms to Individualize Dosing of Warfarin
NCT00927862, Phase 2, Phase 3, Completed, Intermountain Health Care, Inc.; results first posted 2012-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Applying Pharmacogenetic Algorithms to Individualize Dosing of Warfarin. Trials, record NCT00927862. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00927862
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Applying Pharmacogenetic Algorithms to Individualize Dosing of Warfarin
- NCT number
- NCT00927862
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 2,415 participants, actual
- Lead sponsor
- Intermountain Health Care, Inc.
- Conditions
- Thromboembolism
- Interventions
- IWPC adapted genotype-guided dosing algorithm for warfarin, Modified IWPC genetic-guided warfarin dosing algorithm, Standard of care treatment
- First posted
- 2009-06-25
- Last updated
- 2012-09-25
- Results first posted
- 2012-09-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percent of Out of Range (OOR) International Normalized Prothrombin Time Ratio (INRs) in the Standard and Modified Pharmacogenetic Arms. | 1 month (from day 3 to day 30) | 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. |
| Primary | The Percent of Out of Range (OOR) INRs in Pharmacogenetic-guided Patients and Parallel Controls | 1 month (from day 3 to day 30) | The percent of out of range (OOR) INRs in the pharmacogenetic (PG)-dosing (standard + modified IWPC warfarin algorithms) and parallel controls. A 10% margin outside of the target INR 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 OOR INRs at 1 month. |
| Primary | The Percent of Time in Therapeutic Range (TTR) for the Standard and Modified Pharmacogenetic Algorithms. | 1 month (from baseline to day 30) | The percent of time in therapeutic INR range for the standard and modified pharmacogenetic algorithms at 1 month. To account for laboratory INR-measurement error, a 10% margin inside of the target range was allowed in determine TTR 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 TTR for each patient during 1 month. |
| Primary | The Time in Therapeutic Range (TTR) for the Pharmacogenetic-guided Patients and Parallel Controls | 1 month (from baseline to day 30) | The percent of time in therapeutic INR range for the pharmacogenetic (PG)-dosing (standard + modified IWPC warfarin algorithms) guided patients and parallel controls. To account for laboratory INR-measurement error, a 10% margin inside of the target range was allowed in determine TTR 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 TTR for each patient during 1 month. |
| Secondary | The Percent of INRs ≥4 or ≤1.5 for the Modified IWPC Warfarin Algorithm and the Standard IWPC Warfarin Algorithm | 3 months (baseline to 3 months or to end of warfarin therapy, whichever occurs first) | The percent of INRs ≥4 or ≤1.5 for the pharmacogenetic (modified IWPC warfarin algorithm and the standard IWPC warfarin) algorithms. What is reported is the percent of patients with INRs ≥4 or ≤1.5 at the end of follow-up. |
| Secondary | The Percent of INRs ≥4 or ≤1.5 or SAEs Among the Modified IWPC Warfarin Algorithm and Standard IWPC Warfarin Algorithm. | 3 months (from baseline to 3 months or end of warfarin therapy, whichever occurs first) | What is reported is the percent of patients with INRs ≥4 or ≤1.5 or having experienced a serious adverse event (SAE) at the end of follow-up. |
| Secondary | The Number of INRs Measured up to 3 Months in the Pharmacogenetic (PG) (Modified and Standard) Algorithms and Parallel Controls. | 1-3 months (from baseline to 3 months or end of warfarin therapy, whichever occurs first) | What is reported is the mean number of INRs measured/drawn among the patients in each arm. |
| Secondary | Prediction of a Stable Maintenance Dose Among the Pharmacogenetic (PG)-Guided Dosing Algorithms and the Parallel Controls | 3 months (from baseline to 3 months or until stable dosing is achieved, whichever occurs first) | Prediction of a stable maintenance dose (within 1 mg/day) among the pharmacogenetic (PG)-guided dosing and the parallel control group. For the parallel control group, an empiric starting dose of 5 mg/day was assumed. What is reported is the percent of patients who had their maintenance dose predicted as described above. |
| Secondary | The Percent of INRs ≥4 or ≤1.5 in the Pharmacogenetic (PG)-Guided Dosing Arms and the Parallel Control Arm | 3 months (baseline to 3 months or to end of warfarin therapy, whichever occurs first) | What is reported is the percent of patients with an INR ≥4 or ≤1.5 at the end of follow-up. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percent of Out of Range (OOR) International Normalized Prothrombin Time Ratio (INRs) in the Standard and Modified Pharmacogenetic Arms. | 1 month (from day 3 to day 30) | Patients \>= 18 years of age who have an indication for initiation of warfarin anticoagulation, gave written informed consent, and met other inclusion/exclusion criteria were studied. | percent | MEAN |
| SECONDARY | The Percent of INRs ≥4 or ≤1.5 for the Modified IWPC Warfarin Algorithm and the Standard IWPC Warfarin Algorithm | 3 months (baseline to 3 months or to end of warfarin therapy, whichever occurs first) | All consented, randomized patients who were successfully genotyped and received at least 1 dose of warfarin with at least 1 postdose INR. | percent | MEAN |
| SECONDARY | The Percent of INRs ≥4 or ≤1.5 or SAEs Among the Modified IWPC Warfarin Algorithm and Standard IWPC Warfarin Algorithm. | 3 months (from baseline to 3 months or end of warfarin therapy, whichever occurs first) | All patients receiving at least 1 dose of warfarin were included in safety analyses until 1 week after the last warfarin dose | percent | NUMBER |
| SECONDARY | The Number of INRs Measured up to 3 Months in the Pharmacogenetic (PG) (Modified and Standard) Algorithms and Parallel Controls. | 1-3 months (from baseline to 3 months or end of warfarin therapy, whichever occurs first) | Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls | INRs | MEAN |
| SECONDARY | Prediction of a Stable Maintenance Dose Among the Pharmacogenetic (PG)-Guided Dosing Algorithms and the Parallel Controls | 3 months (from baseline to 3 months or until stable dosing is achieved, whichever occurs first) | Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) and had a stable maintenance dose that could be determined were compared to parallel controls | percent | NUMBER |
| PRIMARY | The Percent of Out of Range (OOR) INRs in Pharmacogenetic-guided Patients and Parallel Controls | 1 month (from day 3 to day 30) | Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls | percent | MEAN |
| PRIMARY | The Percent of Time in Therapeutic Range (TTR) for the Standard and Modified Pharmacogenetic Algorithms. | 1 month (from baseline to day 30) | Patients \>= 18 years of age who have an indication for initiation of warfarin anticoagulation, gave written informed consent, and met other inclusion/exclusion criteria were studied. | percent | MEAN |
| PRIMARY | The Time in Therapeutic Range (TTR) for the Pharmacogenetic-guided Patients and Parallel Controls | 1 month (from baseline to day 30) | Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls. | percent | MEAN |
| SECONDARY | The Percent of INRs ≥4 or ≤1.5 in the Pharmacogenetic (PG)-Guided Dosing Arms and the Parallel Control Arm | 3 months (baseline to 3 months or to end of warfarin therapy, whichever occurs first) | Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls. | percent | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percent of Out of Range (OOR) International Normalized Prothrombin Time Ratio (INRs) in the Standard and Modified Pharmacogenetic Arms. | Standard IWPC Warfarin Dosing Algorithm | 30.6 | 95% Confidence Interval 27.6 to 33.7 | percent | |
| The Percent of Out of Range (OOR) International Normalized Prothrombin Time Ratio (INRs) in the Standard and Modified Pharmacogenetic Arms. | Modified IWPC Warfarin Dosing Algorithm | 31.8 | 95% Confidence Interval 28.8 to 34.8 | percent | |
| The Percent of INRs ≥4 or ≤1.5 for the Modified IWPC Warfarin Algorithm and the Standard IWPC Warfarin Algorithm | Standard IWPC Warfarin Dosing Algorithm | 15.2 | Standard Deviation 20.5 | percent | |
| The Percent of INRs ≥4 or ≤1.5 for the Modified IWPC Warfarin Algorithm and the Standard IWPC Warfarin Algorithm | Modified IWPC Warfarin Dosing Algorithm | 15.4 | Standard Deviation 18.2 | percent | |
| The Percent of INRs ≥4 or ≤1.5 or SAEs Among the Modified IWPC Warfarin Algorithm and Standard IWPC Warfarin Algorithm. | Standard IWPC Warfarin Dosing Algorithm | 53.6 | percent | ||
| The Percent of INRs ≥4 or ≤1.5 or SAEs Among the Modified IWPC Warfarin Algorithm and Standard IWPC Warfarin Algorithm. | Modified IWPC Warfarin Dosing Algorithm | 59.2 | percent | ||
| The Number of INRs Measured up to 3 Months in the Pharmacogenetic (PG) (Modified and Standard) Algorithms and Parallel Controls. | PG Dosing Patients | 7.70 | Standard Deviation 3.99 | INRs | |
| The Number of INRs Measured up to 3 Months in the Pharmacogenetic (PG) (Modified and Standard) Algorithms and Parallel Controls. | Parallel Controls | 7.47 | Standard Deviation 7.27 | INRs | |
| Prediction of a Stable Maintenance Dose Among the Pharmacogenetic (PG)-Guided Dosing Algorithms and the Parallel Controls | PG Dosing Patients | 63.2 | percent | ||
| Prediction of a Stable Maintenance Dose Among the Pharmacogenetic (PG)-Guided Dosing Algorithms and the Parallel Controls | Parallel Controls | 37.6 | percent |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PG Dosing Patients | 504 | |
| Overall Study | STARTED | Parellel/Historical Controls | 1,911 | |
| Overall Study | COMPLETED | PG Dosing Patients | 477 | |
| Overall Study | COMPLETED | Parellel/Historical Controls | 1,866 | |
| Overall Study | NOT COMPLETED | PG Dosing Patients | 27 | |
| Overall Study | NOT COMPLETED | Parellel/Historical Controls | 45 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | INR >=4 or <=1.5 | Blood and lymphatic system disorders | PG Dosing Patients | 75 | 488 | |
| other | INR >=4 or <=1.5 | Blood and lymphatic system disorders | Historical Controls | 511 | 1,866 | |
| serious | adjudicated death, MI, stroke, thromboembolic event, moderate or severe hemorrhage | Cardiac disorders | PG Dosing Patients | 22 | 487 | |
| serious | adjudicated death, MI, stroke, thromboembolic event, moderate or severe hemorrhage | Cardiac disorders | Historical Controls | 162 | 1,726 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PG Dosing Patients | ||
| Total, all-cause mortality | Historical Controls | ||
| Total, other adverse events | PG Dosing Patients | 75 | 488 |
| Total, other adverse events | Historical Controls | 511 | 1,866 |
| Total, serious adverse events | PG Dosing Patients | 22 | 487 |
| Total, serious adverse events | Historical Controls | 162 | 1,726 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22431865 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PG Dosing Patients vs Historical Controls: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00927862
GET https://conductscience.org/api/trials/v1/NCT00927862/registered