Intensified Secondary Prevention Intending a Reduction of Recurrent Events in TIA and Minor Stroke Patients (INSPiRE-TMS) A Randomized Trial Comparing a Patient Centered Support Program Versus Conventional Car
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,082
- 试验地点
- 2
- 主要终点
- Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death
研究概览
简要总结
Patients after TIA or Stroke are at high risk of experiencing a new stroke or myocardial infarction. Poor adherence to evidence based secondary prevention regimens is frequently seen. Support programs for patients may not only improve adherence to recommended therapies but also reduce the recurrence rate of stroke and heart attack. The investigators hypothesize that compared to regular care, a structured and patient centered secondary prevention program will lead to a relative risk reduction of at least 28% of recurrent vascular events.
详细描述
Although effective methods of secondary prevention after stroke or TIA are available, adherence to recommended evidence-based treatments is often poor. Programs for supported secondary prevention after cerebrovascular events with improved health education are promising but have not been evaluated regarding recurrent event reduction so far.
A prospective randomized trial has been started to assess the effectiveness of a patient centered structured support program intending a reduction of recurrent vascular events. Usual care consists of structured information given at discharge as well as regular outpatient care by general practitioners. The support program additionally employs a stepwise intensified support program with up to eight appointments over two years in outpatient clinics. Results of risk factor measurements and assessed adherence to medical recommendations are shared with the patients. They are also offered assistance in finding appropriate physical activities or smoking cessation programs.
Patients are randomized to regular care or regular care plus support program and will be followed-up until the total number of 317 primary endpoints has been reached. The composite primary endpoint consists of stroke, major coronary event and vascular death.
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
- 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
- •Acute cerebrovascular event (either TIA or minor Stroke within 14 days before study inclusion) according to the following definitions:
- •TIA (clinical restitution within 24 hours and ABCD2-Score ≥3) or visible DWI-lesion in MRI
- •Minor stroke (mRankin ≤2 at time of inclusion)
- •Patients with at least one of the following treatable risk factors:
- •Arterial Hypertension
- •Diabetes mellitus
- •Atrial Fibrillation
- •Written informed consent prior to study inclusion
- •Realistic perspective in keeping the outpatient appointments
排除标准
- •Distance from home to study center not in suitable range for keeping the outpatient appointments
- •cognitive impairment jeopardizing adherence to the support program
- •Modified Rankin Score >2 at time of study inclusion
- •Malignant disease with life expectancy of less than 3 years
- •relevant alcohol or other substance abuse (except for nicotine)
- •Stroke or TIA etiology without options for evidence based secondary prevention (e.g. dissection or vasculitis)
结局指标
主要结局
Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death
时间窗: Up to 6 years from inclusion
Stroke: Acute (focal-) neurological syndrome, caused by brain infarction or intracerebral hemorrhage Major coronary event:Including instable Angina pectoris, STEMI and non-STEMI Vascular death: Caused by stroke (within 30 days of event), or major coronary event (within 7 days of event), or non-cerebral hemorrhage, or by peripheral arterial disease 30 days after vascular event or vascular intervention (intraarterial or surgical), or by pulmonary embolism or sudden death if death occurs within 24 hours in a patients with previously stable and healthy state if no non-vascular cause is documented
次要结局
- Days alive and at home(Participants will be followed-up for an average of approximately 3.5 years)
- All hospital admissions(Participants will be followed-up for an average of approximately 3.5 years)
- Non vascular death(Participants will be followed-up for an average of approximately 3.5 years)
- Other vascular diseases leading to hospital admission (excl. primary outcome measure)(Participants will be followed-up for an average of approximately 3.5 years)
- All hospital admissions with vascular intervention (intraarterial or surgical)(Participants will be followed-up for an average of approximately 3.5 years)
- Bleedings(Participants will be followed-up for an average of approximately 3.5 years)
- Level of dependency(Up to 6 years from inclusion)
研究者
Heinrich J Audebert
Head of Neurology at Campus Benjamin Franklin, Clinical Professor
Charite University, Berlin, Germany