CSP #481 - The Home INR Study (THINRS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,922
- 试验地点
- 58
- 主要终点
- Time to First Event (Death, Stroke, Major Bleed)
研究概览
简要总结
Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for patient self-testing (PST) is that, compared to conventional high quality anticoagulation management (HQACM), it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding. The secondary hypothesis is that PST and HQACM will be comparable in terms of health care utilization and cost.
详细描述
Intervention: Weekly patient self-testing (PST) of prothrombin time by international normalized ratio (PT INR) versus conventional monthly high quality anticoagulation management (HQACM) from an anticoagulation clinic with a minimum two years follow-up.
Primary Hypothesis: Compared to conventional monitoring in the clinic, PST of anticoagulation intensity will decrease the number of events of thromboembolism (strokes), bleeding, and all cause deaths and improve the quality of anticoagulation.
Second Hypothesis: PST and conventional monitoring will be comparable in terms of health care utilization and cost.
Primary Outcomes: Event rates (thromboembolism or bleeding episodes), time to first event, time within therapeutic range for anticoagulation intensity, and total health care cost (including price of PST monitors) and utilization.
Study Abstract: Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for PST is that it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •To be enrolled in this study, patients must:
- •have AF and/or a MHV;
- •be scheduled to receive warfarin indefinitely (operationally defined as 2 years);
- •be using warfarin according to the criteria described in the Coumadin package insert (no off-label uses);
- •be expected to survive for the duration of the study;
- •not be suffering from intracranial bleeding (intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) or any other contraindication described in the Coumadin package insert;
- •be willing to perform PST;
- •be willing to be randomized;
- •possess adequate cognitive and language skills to follow the protocol and all related instructions;
- •be willing to participate for the full duration of the study;
- •sign the informed consent form; and
- •not be enrolled in another randomized clinical trial that involves a drug or device intervention.
排除标准
- •Patients are excluded in this study if:
- •subject has had intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
- •subject enrolled in another randomized clinical trial that involves a drug or device intervention
- •subject is not able to follow the protocol and all related instructions, and does not have a caregiver with these skills
结局指标
主要结局
Time to First Event (Death, Stroke, Major Bleed)
时间窗: Time to event
Time to first event (death, stroke, major bleed) The primary outcome was time to first event, and we used the Kaplan-Meier method to compare survival curves and the results using the log-rank test. The number of patients with a primary outcome is what was reported in the NEJM paper. Below is the unpublished cumulative incidence information.
次要结局
- Health Care Costs at 2 Year(After 2 years of follow-up for each subject)
- Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)(Full length of follow-up; average of 3 years)
- DASS at 2 Years of Follow-up(At two years of follow-up)
- Cumulative Gain in Health Utilities at 2 Year(After 2 years of follow-up for each subject)