STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,456
- 试验地点
- 2
- 主要终点
- Recurrent symptomatic ICH
研究概览
简要总结
The SATURN trial aims to determine whether continuation vs. discontinuation of statin drugs after spontaneous lobar intracerebral hemorrhage (ICH) is the best strategy; and whether the decision to continue/discontinue statins should be influenced by an individual's Apolipoprotein-E (APOE) genotype.
An MRI ancillary study (SATURN MRI), in a subset of SATURN participants , will evaluate the effects of continuation vs. discontinuation of statin drugs on hemorrhagic and ischemic MRI markers of cerebral small vessel disease, and whether the presence/burden of hemorrhagic markers (i.e. cerebral microbleeds and/or cortical superficial siderosis) on baseline MRI influences the risk of ICH recurrence on/off statin therapy.
详细描述
SATURN is a multi-center, pragmatic, prospective, randomized, open-label, and blinded end-point assessment (PROBE) clinical trial. A total of 1,456 patients presenting within 7 days of a spontaneous lobar ICH while taking statins will be randomized to one of two treatment strategies: discontinuation vs. continuation of statin therapy (using the same agent and dose that they were using at ICH onset). Participating subjects will undergo baseline testing for APOE genotype and will be followed for 24 months to assess for the occurrence of recurrent symptomatic ICH or major adverse cerebro-/cardio-vascular events (MACCE) during the follow-up period. A subset of SATURN participants will participate in the optional MRI study, where they will undergo a baseline MRI within 7 days of randomization into SATURN and a repeat MRI at the end of the follow-up period.
Recruitment will take place at ~ 140 sites coordinated through the NIH/NINDS StrokeNet and the Canadian Stroke Consortium.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years.
- •Spontaneous lobar ICH confirmed by CT or MRI scan
- •Patient was taking a statin drug at the onset of the qualifying/index ICH
- •Randomization can be carried out within 7 days of the onset of the qualifying ICH
- •Patient or legally authorized representative, after consultation with the statin prescriber, agrees to be randomized to statin continuation (restart) vs. discontinuation
排除标准
- •Suspected secondary cause for the qualifying ICH, such as an underlying vascular abnormality or tumor, trauma, venous infarction, or hemorrhagic transformation of an ischemic infarct.
- •History of recent myocardial infarction (attributed to coronary artery disease) or unstable angina within the previous 3 months
- •Diabetic patients with history of myocardial infarction or coronary revascularization
- •History of familial hypercholesterolemia
- •Patients receiving proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors
- •Known diagnosis of severe dementia
- •Inability to obtain informed consent
- •Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, or other obvious reasons for noncompliance, such as unable to adhere to the protocol specified visits/assessments.
- •Life expectancy of less than 24 months due to co-morbid terminal conditions.
- •Pre-morbid mRS >3
- •ICH score >3 upon presentation.
- •Contraindications to continuation/resumption of statin therapy, such as significant elevations of serum creatinine kinase and/or liver transaminases, and rhabdomyolysis
- •Woman of childbearing potential
- •Concurrent participation in another research protocol for investigation of experimental therapy.
- •Indication that withdrawal of care will be implemented for the qualifying ICH.
研究组 & 干预措施
Statin
The same statin agent and dose that subjects were using at the time of ICH onset.
干预措施: Statins (Drug)
No-statin
Subjects will discontinue the statin agent that they were taking at the time of ICH onset. No placebo will be prescribed for these subjects.
结局指标
主要结局
Recurrent symptomatic ICH
时间窗: within 24 months
次要结局
- Major Adverse Cerebro- and Cardio-Vascular Events(Within 24 months)
研究者
Magdy H Selim, MD, PhD
Professor of Neurology
Beth Israel Deaconess Medical Center