Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00143715 · ClinicalTrials.gov registry record · Phase 3
Oral Vitamin K for Warfarin Associated Coagulopathy
A Phase 3 study, sponsored by St. Joseph's Healthcare Hamilton.
- Completed
- Registry status
- Phase 3
- Development phase
- 690
- Enrollment target
NCT00143715 is a Phase 3 study that has completed, run by St. Joseph's Healthcare Hamilton. The registered enrollment target is 690 participants.
The verdict
NCT00143715, a Phase 3 study, has completed, sponsored by St. Joseph's Healthcare Hamilton.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 690 participants
- Enrollment target
Study Summary
Excessive prolongation of the international normalized ratio (INR) occurs frequently in patients taking warfarin; in fact, about one in six INR values is above the desired range. Excessive prolongation of the INR is clinically important because the risk of bleeding approximately doubles for each one point increase in the INR beyond the usual therapeutic range. Thus, treatment strategies which rapidly and reliably lower an excessively prolonged INR into the desired range have the potential to reduce bleeding. When taken by patients with INR values between 4.5 and 10, a small dose of oral vitamin K (1 mg to 2.5mg) reduces the INR into the desired INR range in about 75% of cases within 24 hours of its administration. If warfarin is simply withheld, and no vitamin K is given, about 25% of patients will have an INR in the desired range at 24 hours. However, vitamin K is rarely given to such patients. In a recent survey carried out by our group, less than 20% of such patients would have been given low dose oral vitamin K by a group of physicians who regularly supervise warfarin therapy. The most common treatment for excessive prolongation of the INR is to simply withhold warfarin and allow the INR to fall into the therapeutic range. Although this strategy is effective its safety has never been adequately examined. In fact, recent evidence suggests that patients with INR values of more than 6.0 who are treated with simple warfarin withdrawal have a risk of major bleeding of 4% in the two weeks after they develop their prolonged INR. When asked why they did not give oral vitamin K to a non-bleeding patient who has an excessively prolonged INR, physicians generally give one of three reasons: (1)They are not convinced that oral vitamin K reduces bleeding. (2) They are concerned that oral vitamin K may cause thrombosis. (3) In contrast with simply withholding warfarin, giving oral vitamin K requires a patient to visit the physician, and the physician must have a supply of vi
Interventions
- DRUG Phytonadione (Vitamin K1)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 690 participants |
| Start Date | 2004-09 |
| Est. Completion | 2007-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00143715
The ClinicalTrials.gov registry entry for NCT00143715 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 690 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Joseph's Healthcare Hamilton, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Phytonadione (Vitamin K1) is the first listed.
NCT00143715 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00143715 about?
NCT00143715 is a clinical study titled "Oral Vitamin K for Warfarin Associated Coagulopathy". Excessive prolongation of the international normalized ratio (INR) occurs frequently in patients taking warfarin; in fact, about one in six INR values is above the desired range. Excessive prolongation of the INR is clinically important because the risk of bleeding approximately doubles for each one...
What is the current status of trial NCT00143715?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 690 participants. The study started on 2004-09. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00143715?
The interventions under investigation include: Phytonadione (Vitamin K1) (DRUG).
Who is sponsoring clinical trial NCT00143715?
This trial is sponsored by St. Joseph's Healthcare Hamilton, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.