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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: Completed Phase 3 study, sponsored by St. Joseph's Healthcare Hamilton.

NCT00143715 is a Phase 3 study that has completed, run by St. Joseph's Healthcare Hamilton. The registered enrollment target is 690 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 690 participants
Start Date 2004-09
Est. Completion 2007-01
Phase Phase 3
St. Joseph's Healthcare Hamilton

3 total trials

What the finished NCT00143715 record still lists

NCT00143715 is an interventional study that assigns participants to a tested intervention. The registered 690 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower).

The record links to 0 conditions, and to 1 intervention - of which Phytonadione (Vitamin K1) is the first listed.

NCT00143715 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00143715's enrollment target sits among peer trials

690 524th of 2000 higher than 1,476 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00143715, the US trial registry maintained by the National Library of Medicine. NCT00143715 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.