CTRI/2026/07/113277招募中不适用
A Multicentric, Prospective Study To Generate Real World Evidence On The Use Of Vitamin K Antagonists In Valvular Heart Disease In India - NIL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study
- •1 Adult patients of either sex, aged greater than equal to 18 to less than equal to 80 years
- •2 Patients with a recent diagnosis of valvular heart disease VHD who have been initiated on treatment with oral Vitamin K Antagonists VKAs acenocoumarol or warfarin, as per the treating physicians clinical judgment, for one of the following indications.
- •a. VHD Patients Undergoing Valve Replacement Surgery.
- •b. Patient undergoing valve repair procedures started on VKAs post intervention.
- •3 Patients willing and able to provide written informed consent.
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study
- •Patients with renal impairment & not suited for VKA treatment as per investigators judgement
- •Patients with significant liver disease i.e. cirrhosis and not suited for VKA treatment as per investigators judgement
- •Patients with active or high-risk bleeding
- •Patients not willing to sign PAF
- •Patients with alcohol abuse
- •Patients who are allergic or intolerant to Acenocoumarol and Warfarin.
- •Pregnancy or breastfeeding women
研究者
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