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NCT01474460 · ClinicalTrials.gov registry record · NA
Use of Phytonadione to Reduce International Normalized Ratio (INR) Variability in Patients on Long-term Warfarin Therapy
A NA study, sponsored by James A. Haley Veterans Administration Hospital.
- Completed
- Registry status
- NA
- Development phase
- 370
- Enrollment target
NCT01474460 is a NA study that has completed, run by James A. Haley Veterans Administration Hospital. The registered enrollment target is 370 participants.
The verdict
NCT01474460, a NA study, has completed, sponsored by James A. Haley Veterans Administration Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 370 participants
- Enrollment target
Study Summary
Background: Warfarin is used as an anti-coagulant in patients at risk of developing thrombosis. It has a narrow therapeutic index necessitating close monitoring of International Normalized Ratio (INR). According to a meta-analysis, patients were in therapeutic range only 63.6% of the time. This increases the risk of bleeding or thrombosis. Various retrospective and prospective studies have looked at supplementation with phytonadione in these patients to reduce the variability of INR showing an improvement in variability. Most of these studies have only been done in a small number of patients already on warfarin therapy. This study will focus on patients newly starting warfarin therapy. Methods: This study is a prospective, randomized, controlled trial performed at James A. Haley Veterans' Hospital (JAHVA). Patients who meet criteria and sign informed consent will receive either phytonadione with warfarin or warfarin alone. Based on a power calculation for 80%, a total of 370 patients will be enrolled (185 participants in each arm). Participants will be randomized to either intervention or control. Intervention group participants will be prescribed their usual starting dose of warfarin along with 200 mcg phytonadione by mouth daily. Control group participants will be prescribed their usual starting dose of warfarin. Both groups will follow the usual standard of care. They will come in for a follow-up INR and warfarin dose titration at least once per week until therapeutic, and then as instructed up to every 6 weeks thereafter. Both groups will participate in anticoagulation clinic activities that constitute the current standard of care. Intervention will last for a total of 6 months for each participant once enrolled. Hypothesis:Participants in the intervention group being supplemented with 200mcg of phytonadione will spend more total time with a therapeutic INR than participants in the control group.
Interventions
- DIETARY_SUPPLEMENT phytonadione
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01474460
The ClinicalTrials.gov registry entry for NCT01474460 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James A. Haley Veterans Administration Hospital, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which phytonadione is the first listed.
NCT01474460 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01474460 about?
NCT01474460 is a clinical study titled "Use of Phytonadione to Reduce International Normalized Ratio (INR) Variability in Patients on Long-term Warfarin Therapy". Background: Warfarin is used as an anti-coagulant in patients at risk of developing thrombosis. It has a narrow therapeutic index necessitating close monitoring of International Normalized Ratio (INR). According to a meta-analysis, patients were in therapeutic range only 63.6% of the time. This incr...
What is the current status of trial NCT01474460?
This trial is currently completed. It is a NA study. The enrollment target is 370 participants. The study started on 2011-09. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01474460?
The interventions under investigation include: phytonadione (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01474460?
This trial is sponsored by James A. Haley Veterans Administration Hospital, which has 7 total clinical trials registered on ClinicalTrials.gov.
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