Changes in Oral Vitamin K Intake for Optimization of Chronic Oral Anticoagulation: A Randomized Trial

Hospital de Clinicas de Porto Alegre2 个研究点分布在 1 个国家目标入组 114 人开始时间: 2006年8月1日最近更新: 2008年5月8日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Hospital de Clinicas de Porto Alegre
入组人数: 114
试验地点: 2
主要终点: Percentage of patients on target International Normalized Ratio (prothrombin time) on day 90th after randomization

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary hypothesis of this trial is that changes in oral vitamin K intake, based on simple food registries, may be superior to conventional changes in doses of medications in order to stabilize chronic oral anticoagulation.

研究设计

研究类型: Interventional
分配方式: 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

•Patients with any clinical indication for chronic oral anticoagulation with one INR level out of target, without a clear clinical cause for INR instability (unplanned changes in coumadin medications, other pharmacological interactions, clinical illnesses and laboratory errors).

排除标准

•Clinical evidence of bleeding or thrombosis.
•INR > 4 or INR < 1,5.

结局指标

主要结局

Percentage of patients on target International Normalized Ratio (prothrombin time) on day 90th after randomization

Stabilization of International Normalized Ratio (prothrombin time) during follow-up (90 days after randomization)

次要结局

未报告次要终点

研究者

发起方

Hospital de Clinicas de Porto Alegre

申办方类型

Other

研究点 (2)

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