Preventing Recurrent Vascular Events and Neurological Worsening Through Intensive Organized Case-Management (PREVENTION) Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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:
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
- Double (Investigator, Outcomes Assessor)
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
- •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.
排除标准
- •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).
研究组 & 干预措施
Intensive pharmacist case management
干预措施: Antihypertensive agents and lipid lowering therapy (Drug)
Usual care
干预措施: Usual Care (Other)
结局指标
主要结局
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.
时间窗: 6 months
次要结局
- Change in systolic blood pressure (in mm Hg) and in LDL cholesterol (in mmol/L). Multiple other secondary outcomes as detailed in full protocol.(6 months)