Perioperative Intensive Statin Therapy for Neuroprotection in Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- The number of new ischemic lesions on brain DW-MRI on the third day after TAVR
研究概览
简要总结
Transcatheter aortic valve replacement (TAVR) has become the most anticipated treatment method in the cardiovascular field in recent years, experiencing rapid development. However, neurological complications related to the surgery, such as ischemic injury, stroke, transient ischemic attack, and postoperative delirium, remain the main causes of increased postoperative mortality. Currently, there are limited measures for neuroprotection during the perioperative period of TAVR, and controversy continues over the effectiveness of intraoperative cerebral device placement. Consequently, strategies for neuroprotection during TAVR require active exploration. Previous studies have shown that statins have pleiotropic effects. In addition to inhibiting cholesterol synthesis, it also exhibits anti-inflammatory, antioxidant, stress-reducing, and platelet aggregation-inhibiting properties, as well as potential neuroprotective effects. The efficacy and safety of intensive statin therapy during the perioperative period of percutaneous coronary intervention have been extensively examined, and its role in improving long-term prognosis has been recognised. Since coronary heart disease and aortic valve stenosis share similar pathophysiological mechanisms, the use of statins in valve replacement surgery has also demonstrated positive effects. Research indicates that preoperative high-intensity statin therapy can reduce the incidence of stroke or transient ischemic attack following valve replacement surgery. Additionally, evidence suggests that preoperative statin use can decrease the occurrence of postoperative delirium. However, no evidence exists on whether perioperative intensive statin therapy during TAVR can reduce cerebral ischaemic injury and provide neuroprotection. This study aims to conduct a prospective, randomised, double-blind, multicentre clinical trial to evaluate the neuroprotective effects of statin-enhanced therapy during the perioperative period of TAVR and to investigate whether it can reduce cerebral ischaemic injury after TAVR.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥65-80 years with symptomatic severe aortic stenosis at the time of screening for enrollment;
- •It is planned to undergo transcatheter aortic valve replacement at a scheduled time;
- •Informed consent from the patient or the guardian;
- •American Society of Anesthesiologists (ASA) classification I-III;
- •Possess comprehensive reading, listening, and speaking abilities, and be able to cooperate in completing neuropsychological tests
排除标准
- •Impaired preoperative cognitive function, with a Montreal Cognitive Assessment score of ≤20;
- •Previous history of disabling stroke (modified Rankin Scale score ≥3) or carotid stenosis exceeding 70%, or severe stenosis of the subclavian artery or brachiocephalic trunk;
- •Preoperative baseline MRI indicated acute or subacute ischemic brain injury;
- •Have taken statins within the past month;
- •Renal failure (glomerular filtration rate (GFR) <30 mL/min/1.73 m2);
- •Allergic to atorvastatin;
- •Contraindications to atorvastatin (active liver disease with unexplained persistent elevation of liver enzymes/history of muscle disease);
- •Patients with permanent pacemaker implantation or those who cannot undergo MRI due to claustrophobia;
- •Severe systemic disease with an expected life expectancy of less than 90 days;
- •There are any other medical or non-medical reasons, such as inability to comply with research procedures or follow-up, or plans to relocate during the study period, that the researcher deems unsuitable for the subject to participate in the study
研究组 & 干预措施
Intensive Statin Group
干预措施: Intensive statin treatment (Drug)
Controll Group
干预措施: Placebo Control (Drug)
结局指标
主要结局
The number of new ischemic lesions on brain DW-MRI on the third day after TAVR
时间窗: Day 3
Compared to baseline DW-MRI, the number of newly discovered cerebral ischemic lesions in the subjects on the third day after randomization and surgery, as assessed by cranial DW-MRI scans.
次要结局
未报告次要终点
研究者
Pan Xiangbin
Vice President of Fuwai Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital