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NCT00032591 · ClinicalTrials.gov registry record · Phase 4
The Home INR Study
A Phase 4 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 4
- Development phase
- 2,922
- Enrollment target
NCT00032591: Completed Phase 4 study, sponsored by US Department of Veterans Affairs.
NCT00032591 is a Phase 4 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 2,922 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (464% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00032591, a Phase 4 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 2,922 participants
- Enrollment target
Study Summary
Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for patient self-testing (PST) is that, compared to conventional high quality anticoagulation management (HQACM), it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding. The secondary hypothesis is that PST and HQACM will be comparable in terms of health care utilization and cost.
Primary Outcome
Time to first event (death, stroke, major bleed) The primary outcome was time to first event, and we used the Kaplan-Meier method to compare survival curves and the results using the log-rank test. The number of patients with a primary outcome is what was reported in the NEJM paper. Below is the unpublished cumulative incidence information.
Interventions
- PROCEDURE Weekly patient self-testing of prothrombin time
- OTHER High quality anticoagulation management (HQACM) with conventional monthly testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,922 participants |
| Start Date | 2003-08 |
| Est. Completion | 2008-05 |
| Phase | Phase 4 |
What the finished NCT00032591 record still lists
NCT00032591 is an interventional study that assigns participants to a tested intervention. Its 2,922 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (464% higher).
The record links to 0 conditions, and to 2 interventions - of which Weekly patient self-testing of prothrombin time is the first listed.
NCT00032591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00032591 about?
NCT00032591 is a clinical study titled "The Home INR Study". Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for patie...
What is the current status of trial NCT00032591?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 2,922 participants. The study started on 2003-08. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00032591?
The interventions under investigation include: Weekly patient self-testing of prothrombin time (PROCEDURE), High quality anticoagulation management (HQACM) with conventional monthly testing (OTHER).
Who is sponsoring clinical trial NCT00032591?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00032591's enrollment target sits among peer trials
2,922 25th of 2000 higher than 1,976 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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