Aortic StenosisPhase 4PISTNTNCT07087379

Perioperative Intensive Statin Therapy for Neuroprotection in TAVR（PISTNT）

A Phase 4 study testing Intensive statin treatment in people with Aortic Stenosis and Cerebral Ischaemic Injury, run by Pan Xiangbin.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 65 to 80 years
Conditions the study is for: Aortic Stenosis, Cerebral Ischaemic Injury
What is being tested?: Intensive statin treatment
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 500 participants
Where: No sites listed yet
Study dates: 1 Oct 2025to 1 Jan 2028
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 80 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Who cannot join

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;

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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

About this study

Official title: Perioperative Intensive Statin Therapy for Neuroprotection in Transcatheter Aortic Valve Replacement

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
Being tested: Intensive statin treatment, Placebo Control
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intensive statin treatmentDrug
Intensive statin group:
Atorvastatin 80mg, orally administered 12 hours before surgery Atorvastatin 80mg, orally administered 2 hours before surgery
Placebo ControlDrug
Placebo, tablets, oral administration 12 hours before surgery Placebo, tablet, oral administration 2 hours before surgery

Study groups in NCT07087379
Study group	Role	What they receive
Intensive Statin Group	Experimental	Not described Receives: Drug: Intensive statin treatment
Controll Group	Placebo comparator	Not described Receives: Drug: Placebo Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20251 Jan 2028

First posted28 Jul 2025
Study start1 Oct 2025 (estimated)
Primary completion1 Oct 2027 (estimated)
Study completion1 Jan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Aortic StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07087379
Sponsor's protocol ID: 2025-055-01
Other IDs: 2025YFKT-ZL-09
Acronym: PISTNT
Status last verified: Jul 2025
First submitted: 17 Jul 2025
Last updated: 28 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Perioperative Intensive Statin Therapy for Neuroprotection in Transcatheter Aortic Valve Replacement
ClinicalTrials.gov ID: NCT07087379
Acronym / sponsor ID: PISTNT / 2025-055-01
Conditions: Aortic Stenosis, Cerebral Ischaemic Injury
Phase: Phase 4
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 500 participants (estimated)
Lead sponsor: Pan XiangbinUniversity, hospital or other
Study start: 1 Oct 2025 (estimated)
Primary completion: 1 Oct 2027 (estimated)
Study completion: 1 Jan 2028 (estimated)
First posted: 28 Jul 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intensive Statin Group	Experimental	Drug: Intensive statin treatment
Controll Group	Placebo comparator	Drug: Placebo Control

Who may qualify

Ages: 65 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intensive statin treatmentIntensive statin group: Atorvastatin 80mg, orally administered 12 hours before surgery Atorvastatin 80mg, orally administered 2 hours before surgery	Drug	Intensive Statin Group
Placebo ControlPlacebo, tablets, oral administration 12 hours before surgery Placebo, tablet, oral administration 2 hours before surgery	Drug	Controll Group

Primary outcome

The number of new ischemic lesions on brain DW-MRI on the third day after TAVR
Time frame: 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.

Related trials for Aortic Stenosis

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intensive statin treatment in people with Aortic Stenosis and Cerebral Ischaemic Injury, run by Pan Xiangbin.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of new ischemic lesions on brain DW-MRI on the third day after TAVR (time frame: Day 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07087379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.