Use of statins in patients with intracerebral hemorrhage
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 30
- 主要终点
- The main efficacy endpoint is the impact of continuing vs. discontinuing statins on the risk of recurrent symptomatic intracerebral hemorrhage (ICH) over a 24-month follow-up period. The safety primary endpoint focuses on the occurrence of major adverse cardiac and cerebrovascular events (MACCE), including ischemic stroke, myocardial infarction, and vascular death
研究概览
简要总结
EFFICACY: To determine the effects of continuation vs. discontinuation of statins on the risk of ICH recurrence during 24 months of follow-up in patients presenting with a spontaneous lobar lCH while taking a statin drug. Specifically, we wish to determine the effects of discontinuing vs. continuing statins on the risk of recurrent symptomatic ICH. We hypothesize that discontinuation of statins in patients with lobar ICH is likely associated with reduced risk of ICH recurrence. SAFETY: To determine the effects of discontinuation vs. continuation of statins on the occurrence of any of the following major adverse cardiac and cerebrovascular events (MACCE): symptomatic ischemic stroke, symptomatic myocardial infarction, newly symptomatic arterial occlusive disease (peripheral, retinal, or carotid), revascularization procedures for coronary, carotid, or peripheral arterial disease, and vascular death. We specifically wish to estimate the relative and absolute effects of discontinuing statins on the risk of these MACCE during the 24 month follow-up period. We hypothesize that discontinuation of statins is likely associated with an increase in the risk of MACCE.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 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 must be carried out within 7 days of the onset of the qualifying ICH
- •Patient or LAR, after consultation with the physicians prescribing statin, 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.
- •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
- •Concurrent participation in another research protocol for investigation of experimental therapy
- •Women of childbearing potential
- •Indication that withdrawal of care will be implemented for the qualifying ICH.
- •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.
结局指标
主要结局
The main efficacy endpoint is the impact of continuing vs. discontinuing statins on the risk of recurrent symptomatic intracerebral hemorrhage (ICH) over a 24-month follow-up period. The safety primary endpoint focuses on the occurrence of major adverse cardiac and cerebrovascular events (MACCE), including ischemic stroke, myocardial infarction, and vascular death
The main efficacy endpoint is the impact of continuing vs. discontinuing statins on the risk of recurrent symptomatic intracerebral hemorrhage (ICH) over a 24-month follow-up period. The safety primary endpoint focuses on the occurrence of major adverse cardiac and cerebrovascular events (MACCE), including ischemic stroke, myocardial infarction, and vascular death
次要结局
- Secondary endpoints include quality of life, cognitive and functional outcomes, measured through the EQ-5D questionnaire, modified Rankin Scale (mRS), and Telephone Montreal Cognitive Assessment (T-MoCA). Additionally, the document examines the effects of APOE ε4 and ε2 genotypes on the risk of recurrent ICH
研究者
Alejandra Espinosa
Scientific
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau