WARSS-HEMOSTATIC SYSTEM ACTIVATION SUBSTUDY (WARSS/HAS)

WARSS-止血系统激活子研究（WARSS/HAS）

• 批准号: 2519964
• 负责人: J P KISTLER
• 金额: $ 10.51万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-01 至 1998-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2519964
• 关键词: aspirin; cardiovascular disorder chemotherapy; cardiovascular disorder epidemiology; cerebral ischemia /hypoxia; disease /disorder proneness /risk; drug resistance; fibrinogen; hemostatics; human subject; human therapy evaluation; longitudinal human study; prothrombin; stroke; thrombin; thromboembolism; warfarin

The aims of this study are to determine the level of activity of the hemostatic system (in vivo thrombin generation) in patients who have suffered a previous ischemic stroke. We will measure the plasma level of the prothrombin activation fragment Fl+2, in a representative subset of patients in the Warfarin Aspirin Recurrent Stroke Study (WARSS - NINDS 5 R0l NS2837I). In that study, patients who have suffered a "cryptogenic" (embolic) stroke are assigned to either antithrombotic or antiplatelet therapy. The treatment arms consist of warfarin to maintain INR between 1.4 and 2.8, or aspirin at 325 mg/day. For this substudy of WARSS, we hypothesize that Patients with previous embolic stroke will have a higher level of Fl+2 than patients with other types of ischemic stroke. We will determine whether prothrombin fragment Fl+2 is lowered to a greater extent by warfarin than by aspirin in the embolic "cryptogenic" group of patients as compared to patients in the other stroke groups (atherothrombotic, tandem arterial pathology, small vessel/lacunar). In addition to prothrombin fragment Fl+2 and INR, we will measure serum fibrinogen, albumin/globulin ratios and complete blood counts. To determine whether the relationships between the various parameters are stable over time, plasma samples will be obtained every six months for 2.5 years. Our proposed studies provide the opportunity to answer the following questions: (a) is there a particular group of patients that have a higher level of prothrombin generation?; (b) is there a particular subgroup of patients who are resistant to warfarin-induced thrombin generation?; (c) if warfarin is effective in preventing secondary stroke at the target INR, what is the relation between INR and Fl+2?; and (d) are these relationships stable over time?

这项研究的目的是确定 患者的止血系统（体内凝血酶产生） 遭受了先前的缺血性中风。 我们将测量等离子水平 凝血酶原激活片段fl+2，在代表性子集中 华法林阿司匹林复发性中风研究中的患者（战争-Ninds 5 R0L NS2837I）。 在这项研究中，患有“隐源性”的患者 （栓塞）中风分配给抗血栓形成或抗血小板 治疗。 治疗臂由华法林组成，以维持INR 1.4和2.8，或以325毫克/天为阿司匹林。 对于这种战争的物质，我们 假设患有先前栓塞中风的患者将具有更高的 与其他类型缺血性中风的患者相比，FL+2的水平。 我们将 确定凝血酶原片段是否在更大程度上降低 由华法林（Warfarin）而不是阿司匹林（Asporin 与其他中风组的患者相比（动脉粥样硬化， 串联动脉病理，小血管/lacunar）。 此外 凝血酶原片段fl+2和inr，我们将测量血清纤维蛋白原， 白蛋白/球蛋白的比率和完整的血液计数。 确定是否 随着时间的流逝，各种参数之间的关系稳定， 等离子样品将每六个月获得2。5年。 我们提出的研究提供了回答以下内容的机会 问题：（a）是否有一组特定的患者 凝血酶原的水平？ （b）是否有一个特定的子组 对华法林引起的凝血酶产生的患者？ （C） 如果华法林有效预防目标二次中风，则 INR和FL+2之间的关系是什么？ （d）是这些 随着时间的流逝，关系稳定？