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| ID | Type | Description | Link |
|---|---|---|---|
| 2025YFKT-ZL-09 | Other Grant/Funding Number | Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Statin Group | Experimental |
| |
| Controll Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive statin treatment | Drug | Intensive statin group: Atorvastatin 80mg, orally administered 12 hours before surgery Atorvastatin 80mg, orally administered 2 hours before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The number of new ischemic lesions on brain DW-MRI on the third day after TAVR | 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. | Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo Control | Drug | Placebo, tablets, oral administration 12 hours before surgery Placebo, tablet, oral administration 2 hours before surgery |
|
| D014694 |
| Ventricular Outflow Obstruction |