Perioperative Intensive Statin Therapy for Neuroprotection in TAVR（PISTNT）

NCT07087379 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: 2025-055-012025YFKT-ZL-09
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intensive Statin Group

EXPERIMENTAL

Drug: Intensive statin treatment

Controll Group

PLACEBO COMPARATOR

Drug: Placebo Control

Interventions

Intensive statin treatment DRUG

Intensive statin group: Atorvastatin 80mg, orally administered 12 hours before surgery Atorvastatin 80mg, orally administered 2 hours before surgery

Intensive Statin Group

Placebo Control DRUG

Placebo, tablets, oral administration 12 hours before surgery Placebo, tablet, oral administration 2 hours before surgery

Controll Group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pan Xiangbin: lead

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President of Fuwai Hospital

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 28, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 28, 2025

Record last verified: 2025-07