Coagulation DelayNCT01474460
Use of Phytonadione to Reduce International Normalized Ratio (INR) Variability in Patients on Long-term Warfarin Therapy
A study testing phytonadione in people with Coagulation Delay, run by James A. Haley Veterans Administration Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation Delay
- What is being tested?
- phytonadione
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be eighteen years of age and older
- Have a long-term indication for warfarin (will need to be on warfarin for 6 months or longer)
- Be a new patient on warfarin therapy, or a patient previously on warfarin therapy who has been taken off therapy for more than 2 weeks and needs to be titrated again
- Anticipate receiving medical care at the study site for the duration of the study
- Have transportation to and from the JAHVA
- Have read and signed the Informed Consent document after the study has been fully explained and has had all questions answered
Who cannot join
- Have liver or kidney failure
- Are on hemodialysis or peritoneal dialysis
- Are pregnant or planning to become pregnant
- Have Alzheimer's disease, cognitive impairment, or visual impairment
- Are not compliant with medications
- Are participating in another study
Show all 9Show fewer
- Have scheduled surgery or are planning to undergo major surgery
- Cannot be reached by telephone
- Take over-the-counter vitamin K supplementation except multivitamins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Phytonadione to Reduce 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 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.
Read the detailed description
See above.
- Conditions
- Coagulation Delay
- Being tested
- phytonadione
- Keywords
- warfarin, phytonadione, INR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phytonadioneDietary supplement
Also called Vitamin K, Coumadin
Phytonadione 200mcg PO daily for 6 months + normal dose of warfarin and standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The control group only receiving warfarin therapy (individualized therapy, hence no specific form, dosage, frequency and duration is applicable here - i.e. 5mg daily everyday for 6 months may be applicable to one patient but not all researched patients). Receives: Dietary Supplement: phytonadione |
| Phytonadione | Experimental | Patients receiving 200mcg of phytonadione. Receives: Dietary Supplement: phytonadione |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of this study is to determine the length of time in therapeutic INR range for patients given phytonadione and warfarin compared to warfarin alone
Measured: 6 months
Secondary outcomes (1)
Secondary outcomes include the number of adverse events in the form of bleeding or thrombosis for both groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- James A. Haley Veterans Administration Hospital
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, To-Nga Huynh, PharmD., James A. Haley Veterans Administration Hospital
- Investigators
- To-Nga Huynh, PharmD, Principal investigator, James A. Haley VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474460
- Sponsor's protocol ID
- Pro00000493
- Status last verified
- Mar 2017
- First submitted
- 15 Nov 2011
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Phytonadione to Reduce INR Variability in Patients on Long-term Warfarin Therapy
- ClinicalTrials.gov ID
- NCT01474460
- Acronym / sponsor ID
- Pro00000493
- Conditions
- Coagulation Delay
- Keywords
- warfarin, phytonadione, INR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- James A. Haley Veterans Administration HospitalUS federal agency
- Study start
- Sep 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: phytonadioneThe control group only receiving warfarin therapy (individualized therapy, hence no specific form, dosage, frequency and duration is applicable here - i.e. 5mg daily everyday for 6 months may be applicable to one patient but not all researched patients). |
| Phytonadione | Experimental | Dietary Supplement: phytonadionePatients receiving 200mcg of phytonadione. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be eighteen years of age and older
- Have a long-term indication for warfarin (will need to be on warfarin for 6 months or longer)
- Be a new patient on warfarin therapy, or a patient previously on warfarin therapy who has been taken off therapy for more than 2 weeks and needs to be titrated again
- Anticipate receiving medical care at the study site for the duration of the study
- Have transportation to and from the JAHVA
Key exclusion criteria (9 listed)
- Have liver or kidney failure
- Are on hemodialysis or peritoneal dialysis
- Are pregnant or planning to become pregnant
- Have Alzheimer's disease, cognitive impairment, or visual impairment
- Are not compliant with medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phytonadioneAlso: Vitamin K, CoumadinPhytonadione 200mcg PO daily for 6 months + normal dose of warfarin and standard of care treatment | Dietary supplement | Control group, Phytonadione |
Primary outcome
The primary outcome of this study is to determine the length of time in therapeutic INR range for patients given phytonadione and warfarin compared to warfarin alone
Time frame: 6 months
1 secondary outcome
Secondary outcomes include the number of adverse events in the form of bleeding or thrombosis for both groups.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Coagulation Delay
RecruitingObservational study
External Multicenter Validation of the APTTO Model for Prolonged APTT Using Clot Waveform Analysis
Coagulation Disorder, Blood, Prolonged APTT
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
To-Nga Huynh, PharmD principal investigator
James A. Haley VA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phytonadione in people with Coagulation Delay, run by James A. Haley Veterans Administration Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome of this study is to determine the length of time in therapeutic INR range for patients given phytonadione and warfarin compared to warfarin alone (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.