NCT07087379

Perioperative Intensive Statin Therapy for Neuroprotection in TAVR（PISTNT）

Perioperative Intensive Statin Therapy for Neuroprotection in Transcatheter Aortic Valve Replacement

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Pan Xiangbin · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Aortic Stenosis
• Cerebral Ischaemic Injury

Interventions

Type	Name	Description
DRUG	Intensive statin treatment	Intensive statin group: Atorvastatin 80mg, orally administered 12 hours before surgery Atorvastatin 80mg, orally administered 2 hours before surgery
DRUG	Placebo Control	Placebo, tablets, oral administration 12 hours before surgery Placebo, tablet, oral administration 2 hours before surgery

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-10-01
• Completion: 2028-01-01
• First posted: 2025-07-28
• Last updated: 2025-07-28