Trial · NCT00401414
Study to Develop a Reliable Nomogram That Incorporates Clinical and Genetic Information
NCT00401414, Not applicable, Completed, Brigham and Women's Hospital; results first posted 2013-08-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Develop a Reliable Nomogram That Incorporates Clinical and Genetic Information. Trials, record NCT00401414. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00401414
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Develop a Reliable Nomogram That Incorporates Clinical and Genetic Information
- NCT number
- NCT00401414
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 344 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis, Atrial Fibrillation
- Interventions
- Warfarin
- First posted
- 2006-11-20
- Last updated
- 2013-08-30
- Results first posted
- 2013-08-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percentage of Time That INR Within Therapeutic Range Using Linear Interpolation (Rosendaal et al). | 90 Days | Primary end point: mean percentage of time INR is within therapeutic range. Though target INR was 2.0-3.0, therapeutic INR is considered 1.8-3.2 (allows for INR measurement error and avoids problems inherent in overcorrection). The international normalized ratio (INR) is one way of presenting prothrombin time test results for people taking the blood-thinning medication warfarin. The INR formula adjusts for variation in laboratory testing methods so that test results can be comparable. |
| Secondary | Time to the First Therapeutic INR. | 90 Days | The INR (international normalized ratio) is a derived measure of the prothrombin time. In this trial, a therapeutic INR was considered 1.8 to 3.2 |
| Secondary | Per-patient Percentage of INRs Out of the Therapeutic Range | 90 Days | The INR (international normalized ratio) is a derived measure of the prothrombin time. In this trial, a therapeutic INR was considered 1.8 to 3.2 |
| Secondary | Time to Stable Anticoagulation (in Days). | 90 Days | Defined as two consecutive INRs within the therapeutic range \>7 days apart and with no dose change during this time. |
| Secondary | Proportion of Patients With Serious Adverse Clinical Events. | 90 Days | Defined as an INR\>4.0, use of vitamin K, major bleeding events (as defined by the Thrombolysis in Myocardial Infarction \[TIMI\] criteria), thromboembolic events, stroke (all cause), myocardial infarction, and death (all cause). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Percentage of Time That INR Within Therapeutic Range Using Linear Interpolation (Rosendaal et al). | 90 Days | percentage of time | MEAN | |
| SECONDARY | Time to the First Therapeutic INR. | 90 Days | Days | MEAN | |
| SECONDARY | Per-patient Percentage of INRs Out of the Therapeutic Range | 90 Days | percentage of INRs out of range | MEAN | |
| SECONDARY | Time to Stable Anticoagulation (in Days). | 90 Days | Days | MEAN | |
| SECONDARY | Proportion of Patients With Serious Adverse Clinical Events. | 90 Days | participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Percentage of Time That INR Within Therapeutic Range Using Linear Interpolation (Rosendaal et al). | Dosing Algorithm A | 58.9 | Standard Deviation 22 | percentage of time | |
| Mean Percentage of Time That INR Within Therapeutic Range Using Linear Interpolation (Rosendaal et al). | Dosing Algorithm B | 59.7 | Standard Deviation 23 | percentage of time | |
| Mean Percentage of Time That INR Within Therapeutic Range Using Linear Interpolation (Rosendaal et al). | Dosing Algorithm C | 65.8 | Standard Deviation 16.9 | percentage of time | |
| Time to the First Therapeutic INR. | Dosing Algorithm A | 9.1 | Standard Deviation 4.5 | Days | |
| Time to the First Therapeutic INR. | Dosing Algorithm B | 10.4 | Standard Deviation 4.9 | Days | |
| Time to the First Therapeutic INR. | Dosing Algorithm C | 9.7 | Standard Deviation 4.4 | Days | |
| Per-patient Percentage of INRs Out of the Therapeutic Range | Dosing Algorithm A | 42.2 | Standard Deviation 21.6 | percentage of INRs out of range | |
| Per-patient Percentage of INRs Out of the Therapeutic Range | Dosing Algorithm B | 37.7 | Standard Deviation 22.8 | percentage of INRs out of range | |
| Per-patient Percentage of INRs Out of the Therapeutic Range | Dosing Algorithm C | 33.3 | Standard Deviation 16.8 | percentage of INRs out of range | |
| Time to Stable Anticoagulation (in Days). | Dosing Algorithm A | 50.8 | Standard Deviation 20.1 | Days |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dosing Algorithm A | 118 | |
| Overall Study | STARTED | Dosing Algorithm B | 147 | |
| Overall Study | STARTED | Dosing Algorithm C | 79 | |
| Overall Study | COMPLETED | Dosing Algorithm A | 118 | |
| Overall Study | COMPLETED | Dosing Algorithm B | 147 | |
| Overall Study | COMPLETED | Dosing Algorithm C | 79 | |
| Overall Study | NOT COMPLETED | Dosing Algorithm A | 0 | |
| Overall Study | NOT COMPLETED | Dosing Algorithm B | 0 | |
| Overall Study | NOT COMPLETED | Dosing Algorithm C | 0 |
Source ClinicalTrials.gov
Adverse events12
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 |
|---|---|---|---|---|---|---|
| serious | INR ≥ 4 | Vascular disorders | Dosing Algorithm A | 39 | 118 | 39 |
| serious | INR ≥ 4 | Vascular disorders | Dosing Algorithm B | 36 | 147 | 36 |
| serious | INR ≥ 4 | Vascular disorders | Dosing Algorithm C | 22 | 79 | 22 |
| serious | Major bleeding events (TIMI definition) | Vascular disorders | Dosing Algorithm A | 2 | 118 | 2 |
| serious | Major bleeding events (TIMI definition) | Vascular disorders | Dosing Algorithm B | 3 | 147 | 3 |
| serious | Major bleeding events (TIMI definition) | Vascular disorders | Dosing Algorithm C | 2 | 79 | 2 |
| serious | Vitamin K administration | Investigations | Dosing Algorithm A | 2 | 118 | 2 |
| serious | Vitamin K administration | Investigations | Dosing Algorithm B | 0 | 147 | 0 |
| serious | Vitamin K administration | Investigations | Dosing Algorithm C | 0 | 79 | 0 |
| serious | Thrombotic events (MI, stroke, VTE) | Vascular disorders | Dosing Algorithm A | 0 | 118 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dosing Algorithm A | ||
| Total, all-cause mortality | Dosing Algorithm B | ||
| Total, all-cause mortality | Dosing Algorithm C | ||
| Total, other adverse events | Dosing Algorithm A | 0 | 118 |
| Total, other adverse events | Dosing Algorithm B | 0 | 147 |
| Total, other adverse events | Dosing Algorithm C | 0 | 79 |
| Total, serious adverse events | Dosing Algorithm A | 43 | 118 |
| Total, serious adverse events | Dosing Algorithm B | 41 | 147 |
| Total, serious adverse events | Dosing Algorithm C | 24 | 79 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00401414
GET https://conductscience.org/api/trials/v1/NCT00401414/registered