跳至主要内容
临床试验/NCT06187155
NCT06187155招募中不适用

Impact of Education Level on Clinical Outcomes in Self-INR Managed Patients on Longterm Warfarin: A Single-center Randomized Controlled Study

Cairo University2 个研究点 分布在 1 个国家目标入组 586 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
586
试验地点
2
主要终点
Time and proportion of INR in therapeutic range

研究概览

简要总结

Oral anticoagulation (OAC) is indicated in a wide variety of clinical conditions including atrial fibrillation (AF), mechanical valve prosthesis (MVP), deep vein thrombosis and pulmonary embolism. Although direct OAC has replaced vitamin K antagonists (VKA) in non-valvular AF due to lower bleeding risk, it's still recommended to use VKA specifically in cases of valvular AF, MVP and anti-phospholipid syndrome.

VKA has a narrow therapeutic range and multiple drug interactions causing unpredicted pharmacodynamics. This requires regular monitoring of the international normalized ratio (INR) level to ensure it's in the target therapeutic range and prevent extreme values that may result in thrombo-embolic events or sometimes fatal bleeding.

Self-INR monitoring and management have emerged recently as a safe cost-effective alternative to standard management, with evidence of tighter control of INR, reduction of thrombo-embolic events, and improving treatment-related quality of life. However, there are no specific criteria for patient selection. Whether the level of education and other social factors would affect the outcomes of self-management is still not clear.

Owing to the wide geographical area served by Aswan Heart Center, many patients have to cover long distances to follow up their INR and seek medical advice regarding adequate dose modification. This may result in reluctance and non-compliance to clinic visits and INR testing. Proper education, training and providing an alternative near place to measure the INR and self-adjust warfarin dose is expected to improve patient adherence and compliance.

详细描述

Study Methods

  • Population of study: Patients who have a clinical indication for long term VKA.
  • Study location: Aswan Heart Center.
  • Inclusion criteria: Adult patients above 18 years who are indicated for long term VKA and has been on VKA for more than 6 months.
  • Exclusion criteria:
  1. Refusal to join the study. 2. History of life-threatening bleeding or thrombo-embolic events. 3. Age above 60 years. 4. Illiterate patients with no caregivers living at the same home.
  • Patient informed consent:

Individual informed consent will be taken from every candidate for the study. The candidates will have the right to withdraw from the study at any time without any changes in the clinical service provided to them.

  • Methodology in details:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Adult patients above 18 years who are indicated for long term VKA and has been on VKA for more than 6 months.

排除标准

  • Refusal to join the study.
  • History of prior life-threatening bleeding or thrombo-embolic events.
  • Illiterate patients with no caregivers living at the same home.

结局指标

主要结局

Time and proportion of INR in therapeutic range

时间窗: 6 months

Time in therapeutic range and percentage of test results in therapeutic range

次要结局

  • Thrombo-embolic events(6 months)
  • Major bleeding(6 months)
  • All-cause mortality(6 months)
  • Minor bleeding(6 months)
  • Frequency of testing(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hossameldin Elsayed Khalifa Hussein

Associate Specialist of Adult Cardiology

Magdi Yacoub Heart Foundation

研究点 (2)

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