Use of Daily Vitamin K Supplementation in Patients on Warfarin With a History of Frequent Dose Changes or Variable INRs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of warfarin adjustments required in each phase
研究概览
简要总结
The purpose of this study is to determine if daily Vitamin K supplementation stabilizes INRs in patients taking warfarin with a history of frequent dose changes or variable INRs.
详细描述
Consistent daily Vitamin K intake may contribute to the stabilization of INR values in patients with unstable INRs on warfarin therapy. Subjects with unstable INRs will be identified from the existing patient records of the UNC Anticoagulation Clinics. Eligible subjects will sign an informed consent form and will receive a point-of-care (POC) INR monitoring device. They will undergo 9 weeks of home INR monitoring via the POC device (with monthly clinic follow-up). They will subsequently be provided with 500 mcg Vitamin K tablets to be taken once daily. Weekly POC INR monitoring with monthly clinic follow-up will continue for an additional 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of UNC Anticoagulation Clinic with INR target of 2.0-3.0 and at least 9 months on uninterrupted warfarin
- •Unstable INRs for the past 6 months, defined as a minimum number of warfarin dose changes of 3
- •Patient demonstration of proper POC device technique on 2 measurements during one teaching session with investigator
- •Age greater than or equal to 18 years
排除标准
- •Stroke or TIA within the previous 12 months
- •VTE within the last 3 months
- •Antiphospholipid antibody syndrome
- •Pregnant patients, since warfarin is contraindicated during pregnancy
结局指标
主要结局
Number of warfarin adjustments required in each phase
Time in therapeutic, sub-, and supra-therapeutic range
Variance/SD of INRs for each patient
Adherence assessed by pill counts and pharmacy record review
Thrombotic/bleeding episodes
次要结局
未报告次要终点