StAtins in Frail oldEr patients with ischemic Stroke or Transient ischemic attack
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 1,200
- 试验地点
- 17
- 主要终点
- (1) daily functioning, measured with the The Older Persons and Informal Caregivers Survey Short Form (TOPICS-SF), and (2) health related quality of life, measured using the PROMIS-10 with global mental health and global physical health summary scores, both at two years.
研究概览
简要总结
To assess whether daily functioning and health related quality of life are better at two years when statins are stopped or not initiated, compared to when statins are used, in frail patients of >= 70 years with a recent ischemic stroke or transient ischemic attack.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age = 70 years or older at the time of ischemic stroke or TIA; inclusion within 6 weeks after diagnosis of ischemic stroke or TIA; frailty as defined by a pre-event score of 4-7 and/or post-event score of 6-7 on the validated Clinical Frailty Scale.
排除标准
- •Very severe frailty or very limited life expectancy (< 6 months) as defined by a score >= 8 points on the validated Clinical Frailty Scale; a previous serious adverse drug reaction to statins; not speaking Dutch; being unable to answer questions and have no proxy assessment available; being unable or not willing to give written informed consent (either patient or patient with help from proxy).
结局指标
主要结局
(1) daily functioning, measured with the The Older Persons and Informal Caregivers Survey Short Form (TOPICS-SF), and (2) health related quality of life, measured using the PROMIS-10 with global mental health and global physical health summary scores, both at two years.
(1) daily functioning, measured with the The Older Persons and Informal Caregivers Survey Short Form (TOPICS-SF), and (2) health related quality of life, measured using the PROMIS-10 with global mental health and global physical health summary scores, both at two years.
次要结局
- Secondary outcomes are daily functioning and hrQoL, both at one year. Other secondary outcomes are: physical functioning, functional outcome, cognition, emotional problems, falls, adverse drug events, cardiovascular risk status (based on clinical tests and lab results), general quality of life, societal costs, incidence of cardiovascular event recurrences and mortality - all at one and two years.
研究者
SAFEST onderzoeksgroep
Scientific
Amsterdam UMC