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Preventing Recurrent Vascular Events in Patients With Stroke or Transient Ischemic Attack (PREVENTION)

2018年10月10日 更新者:University of Alberta

Preventing Recurrent Vascular Events and Neurological Worsening Through Intensive Organized Case-Management (PREVENTION) Trial

People who have had a stroke or transient ischemic attack (TIA or "mini-stroke") are at high risk of having another stroke or a heart attack. Conditions like high blood pressure and high cholesterol, along with other lifestyle behaviors (e.g., smoking), substantially increase the risk of stroke and heart disease. Aggressive treatment of these risk factors however, can significantly reduce the chance of another stroke, heart attack or death.

This study will look at different ways to optimize blood pressure and cholesterol levels and educate people about positive lifestyle changes.

研究概览

详细说明

BACKGROUND: Epidemiological studies have shown that a number of conditions increase the risk of stroke and other vascular diseases and there is compelling evidence from large randomized trials that treatment of these risk factors, especially hypertension and high cholesterol, can significantly lower future cardiovascular risk. Survivors of TIA or stroke are at high risk for recurrent stroke, MI, or death (22% at one year) and aggressive treatment of vascular risk factors can reduce the risk of recurrence by over 25%. However, vascular risk factors, especially hypertension and high cholesterol, are not managed optimally in patients after a TIA or stroke, even in those patients seen in specialized Stroke Prevention Clinics (SPCs). This gap between the evidence for secondary prevention of stroke and the clinical reality leads to sub-optimal patient outcomes. There is limited data on interventions proven to improve outcomes in patients with stroke or TIA.

To improve the quality of care for any condition or patient population, one needs to address structure, process, and outcomes. In this study, we will be creating and testing a new structure for delivery of stroke prevention services - we anticipate this new structure will improve processes of care which in turn should lead to improved outcomes.

Hypothesis:

Compared with usual care, we hypothesize that a pharmacist case manager intervention will improve blood pressure and serum lipid levels (by employing standardized treatment protocols to guideline-recommended targets), the management of other risk factors,enhance medication adherence, and increase health-related quality of life.

Design:

A prospective, randomized, controlled open-label with blinded ascertainment of outcomes (PROBE) trial. Patients with a recent stroke or TIA evaluated in any of the 3 stroke prevention clinics (SPC) in Edmonton, Canada,will be randomized to usual care or the "pharmacist case manager intervention".

Usual care patients will will receive the same educational materials about stroke risk factors and medication adherence as the "intervention" patients, will be seen monthly by a study nurse, will have the same number of BP measurements as "intervention" patients, and will have a fax sent to their family physician after each study visit reporting their BP.

Over and above usual care, the intervention group will include intensive pharmacist case-management over 6 months consisting of the following:

  • monthly follow-up visits with focus on vascular protection; these clinic visits will be run parallel to, but independent of, any follow-up at the SPC and will include provision to each patient of their individual cardiovascular disease risk profile using the the CV Health Manager software.
  • Initiation, monitoring and titration of medications related to blood pressure and dyslipidemia, using Canadian national guideline-recommended treatment targets.
  • Medication adherence management on an ongoing basis, including access to Dosettes®, blister packs, and reminder tools as deemed necessary.
  • Independent capacity to refer to allied health services (including dieticians and weight loss services, diabetes education centres, and smoking cessation counselors).
  • Regular feedback to the primary care physician and the stroke specialist of record, regarding all stroke prevention related activities.

研究类型

介入性

注册 (实际的)

279

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alberta
      • Edmonton、Alberta、加拿大、T6G 2B7
        • University of Alberta Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • A stroke specialist-determined ischemic stroke or TIA within the past year (including ocular strokes/TIA such as amaurosis fugax).
  • Presence of systemic hypertension (average systolic blood pressure over two visits - i.e., SPC visit and study screening visit- exceeding 140 mmHg) OR fasting LDL cholesterol exceeding 2.0 mmol/L OR total: HDL cholesterol ratio exceeding 4.0 at SPC visit.

Exclusion Criteria:

  • Neurological event considered to be due to intracranial hemorrhage (e.g., ICH, SAH), or trauma induced, or related to structural heart disease such as ASD/VSD or endocarditis.
  • Foreshortened life-expectancy (e.g., active malignancy), hypertensive crisis (clinic systolic BP > 200 mm Hg), or severe comorbidities.
  • Institutionalized in a long-term care facility.
  • Cognitive impairment (defined as a score of > 5 on the Short Portable Mental Status questionnaire).
  • Already on maximal therapy for risk factors (on 3 antihypertensive drugs at maximal dose if hypertension is inclusion criterion or on maximal dose statin if hyperlipidemia is inclusion criterion).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:日常护理
Monthly education and reinforcement of risk factor modification, and blood pressure measurement.
实验性的:Intensive pharmacist case management
The above agents will be initiated/titrated in accordance to guidelines approved by Canadian Hypertension Education Program and the Canadian Best Practice Recommendations for Stroke Care

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The proportion of subjects who attain "optimal BP and lipid control" (defined as systolic BP < 140 mm Hg AND fasting LDL cholesterol < 2.0 mmol/L) compared to baseline.
大体时间:6 months
6 months

次要结果测量

结果测量
大体时间
Change in systolic blood pressure (in mm Hg) and in LDL cholesterol (in mmol/L). Multiple other secondary outcomes as detailed in full protocol.
大体时间:6 months
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Finlay A McAlister, MD, MSc、Department of Medicine, University of Alberta

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年1月1日

初级完成 (实际的)

2013年5月1日

研究完成 (实际的)

2013年11月1日

研究注册日期

首次提交

2009年6月5日

首先提交符合 QC 标准的

2009年7月1日

首次发布 (估计)

2009年7月2日

研究记录更新

最后更新发布 (实际的)

2018年10月15日

上次提交的符合 QC 标准的更新

2018年10月10日

最后验证

2015年4月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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