Trial record 6 of 36 for:
Open Studies | "Vitamin K"
Does Low Dose Oral Vitamin K Improve International Normalized Ratio (INR) Stability? (OVWAC VII)
This study is currently recruiting participants.
Verified March 2012 by St. Joseph's Healthcare Hamilton
Sponsor:
St. Joseph's Healthcare Hamilton
Collaborators:
McMaster University
University of Western Ontario, Canada
Information provided by (Responsible Party):
Mark Crowther, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00990158
First received: October 5, 2009
Last updated: March 6, 2012
Last verified: March 2012
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Purpose
Warfarin is highly effective for the prevention of both first and recurrent thrombotic events, however even minor excursions outside the reference INR range of 2.0 to 3.0 are associated with bleeding or thrombotic complications. The importance of maintaining the INR within the desired interval has led to the concept of "time in therapeutic range (TTR)" - the total proportion of time that the INR is between 2.0 and 3.0. The investigators propose a multicentre, double blind, randomized trial which will determine if 0.150 mg of oral vitamin K increases time in the therapeutic range for patients receiving warfarin.
| Condition | Intervention | Phase |
|---|---|---|
|
Coagulation Bleeding Thrombosis |
Drug: Phytonadione (Vitamin K1) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicentre Study of Low Dose Oral Vitamin K for INR Control in Patients Receiving Warfarin |
Resource links provided by NLM:
Further study details as provided by St. Joseph's Healthcare Hamilton:
Primary Outcome Measures:
- When compared with placebo does the addition of 150 micrograms of daily vitamin K to "usual warfarin therapy" improve anticoagulant control as measured by "time in the therapeutic range"? [ Time Frame: 7 Months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Does low dose Vitamin K (LDVK) increase the frequency of adverse clinical events, including thromboembolism and major and/or all bleeding? [ Time Frame: 7 Months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 400 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Low dose vitamin K + usual warfarin
Low dose oral vitamin K (0.150 mg orally once daily) + warfarin continuation with usual warfarin monitoring
|
Drug: Phytonadione (Vitamin K1)
A daily dose of 150 micrograms of vitamin K medication given orally for a total of 7 months
|
|
Placebo Comparator: Usual warfarin therapy + placebo
Patients continue usual warfarin and take one placebo per day
|
Drug: Placebo
A daily dose of matching placebo medication given orally for a total of 7 months
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Warfarin therapy administered to a target INR of 2.0 to 3.0
Exclusion Criteria:
- Out of range INR on day of screening - enrolment will only occur if the patient's INR on the day of screening is between 1.8 and 3.4 (inclusive) - if the INR is outside this range the patient will be re-screened when the INR is within this range.
- Recent warfarin initiation - all patients must have received warfarin for a minimum of 3 months
- Planned termination or extended temporary interruption of warfarin within 6 months or anticipated survival of less than 6 months
- Known severe liver disease, known excess alcohol consumption , known malabsorption syndrome or inability to take oral medications
- Use of medications known to interfere with warfarin and whose dose is likely to change over the course of the study (e.g. barbiturates, rifampin etc.)
- Known allergy to vitamin K
- Inability or unwillingness to follow study procedures or provide consent
- Prior participation in this study, or participating in a competing study which may impact INR control
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990158
Contacts
| Contact: Mark A Crowther, MD | 905 521 6024 | crowthrm@mcmaster.ca |
| Contact: Luqi Wang, PhD | 905 522 1155 ext 35948 | wanglu@mcmaster.ca |
Locations
| Canada, Ontario | |
| St. Joseph's Hospital | Recruiting |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Contact: Mark A Crowther, MD 905 521 6024 crowthrm@mcmaster.ca | |
| Contact: Luqi Wang, Ph. D. 905 522 1155 ext 35948 wanglu@mcmaster.ca | |
| Hamilton Health Sciences Centre | Recruiting |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Contact: Sam Schulman 905-528-9946 schulms@mcmaster.ca | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 4G5 | |
| Contact: Michael Kovacs, MD (519) 685-8475 michael.kovacs@lhsc.on.ca | |
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
McMaster University
University of Western Ontario, Canada
Investigators
| Principal Investigator: | Mark A Crowther, MD | McMaster University |
More Information
Additional Information:
Publications:
de Assis MC, Rabelo ER, Avila CW, Polanczyk CA, Rohde LE. Improved Oral Anticoagulation After a Dietary Vitamin K-Guided Strategy: A Randomized Controlled Trial. Circulation 2009 Sep 22;120(12):1115-22.
Crowther MA, Ageno W, Garcia D, Wang L, Witt DM, Clark NP, et al. Effectiveness of low dose oral vitamin K for patients with elevated INR values: results of a randomized trial examining clinical outcomes. Journal of Thrombosis & Haemostasis 5[S2], PS 219. 2008.
| Responsible Party: | Mark Crowther, Vice President, Research, St. Joseph's Healthcare Hamilton |
| ClinicalTrials.gov Identifier: | NCT00990158 History of Changes |
| Other Study ID Numbers: | NA 6695 |
| Study First Received: | October 5, 2009 |
| Last Updated: | March 6, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by St. Joseph's Healthcare Hamilton:
|
Vitamin K1 (phytonadione) Randomized controlled trial Warfarin Coagulopathy Time in therapeutic range |
Bleeding Thrombosis VKORC1 and CYP2C9 genotypes Time INR in therapeutic range |
Additional relevant MeSH terms:
|
Vitamin K 1 Vitamin K Hemorrhage Thrombosis Pathologic Processes Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Vitamins Warfarin Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants Hematologic Agents Therapeutic Uses Anticoagulants |
ClinicalTrials.gov processed this record on May 19, 2013