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Effect of statin for trans-catheter aortic valve implantation

Effect of statin for trans-catheter aortic valve implantation - ES-TAVI

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012388
Enrollment
220
Registered
2013-11-23
Start date
2013-11-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic stenosis

Interventions

Pravastatin group Standard group

Sponsors

St Luke's International Hospital Cardiovascular Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients to who TAVI is scheduled. Patient who has severe AS and symptomatic. AVA is 18-28mm. Distance between annulus-coronary artery>10mm. Creatinine level<2.0mg/dl, Expected life expenctency >1y, Indication for TAVI is decided by heart team. 2) Normal LDL and high LDL patients LDL level must be higher than 50mg/dl in 2 measurements. If less than 50mg/dl, 3rd measurement is allowed. Average LDL level must be higher than 50mg/dl.

Exclusion criteria

Exclusion criteria: 1) Familial hypercholesteremia 2) Previous TAVI 3) Congenital heart disease 4)Severe liver dysfunction or renal dysfunction 5) Nephrotic syndrome 6) Hypothyroidism 7) Cusing syndrome 8) Steroid therapy 9) Past history of allergic reaction for statins 10) pregnant female 11) Unconsented by patients or therapist 12) Patients who has been treated with statins for coronary artery diseases

Design outcomes

Primary

MeasureTime frame
MI Cardiac/non cardiac death stroke Unplanned pacemaker implantation unplanned open chestsurgery Unplanned peripheral vascular intervention/surgical repair Life thretening bleeding Unplanned admossion due to valve failure Acute renal injury with 3-fold increment of serum cretinine level

Secondary

MeasureTime frame
Pressure Gradient Aortic valve Area

Countries

Japan

Contacts

Public ContactHirotsugu Mitsuhashi

St Luke's International Hospital Cardiovascular Center

mitsuhashi3615@yahoo.co.jp03-3541-5151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026