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Clinical trial Recruiting at 1 site Interventional Ages 60 to 95

Using Atorvastatin to prevent postoperative atrial fibrillation in heart surgery patients

Official title: Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement - a Randomized Controlled Trial

Run by Odense University Hospital · NCT05076019 · Data updated 2026-11-12

This study is testing if taking Atorvastatin before and after heart surgery can help prevent a common heart rhythm problem called atrial fibrillation in patients who are having their aortic valve replaced.

More Postoperative Atrial Fibrillation trials

Quick facts

Study typeInterventional
Ages60 Years to 95 Years
SexAll
Enrollment266 (estimated)
SponsorOdense University Hospital
Academic / other
Locations1 site (Odense)
StatusRecruiting
StartedFebruary 1, 2022
Main results expectedDecember 1, 2027
Study endsDecember 1, 2027
Registry record updatedOctober 8, 2024
Trial IDNCT05076019 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients over 60 years old undergoing elective solitary surgical aortic valve replacement who are in sinus rhythm and not on anti-arrhythmic medications.

Probably not a fit

Patients with a prior history of atrial fibrillation or those with significant hepatic or renal dysfunction may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of Atorvastatin, a statin medication, on preventing postoperative atrial fibrillation (POAF) in patients undergoing surgical aortic valve replacement. Participants will be randomly assigned to receive either Atorvastatin 80mg or a placebo starting 7 to 14 days before surgery and continuing until 30 days after the procedure. The study aims to determine if this prophylactic treatment can reduce the incidence of POAF and other complications associated with cardiac surgery. Continuous ECG monitoring will be employed to detect any occurrences of atrial fibrillation during hospitalization.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of postoperative atrial fibrillation and improve recovery outcomes for heart surgery patients.

How similar studies have gone: While the use of statins in this context is promising, the specific application of Atorvastatin for preventing POAF in surgical aortic valve replacement is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patients undergoing elective solitary SAVR with bioprosthesis
2. Patients who are in sinus rhythm and not taking any anti-arrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery
3. No prior use of HMG-CoA reductase inhibitors the last 3 months and at least 7 days prior to the time of surgery
4. Age \>60 years
5. Willingness and provision of informed consent to be randomized

Exclusion Criteria:

1. Prior history of atrial fibrillation
2. Prior history of cardiac surgery
3. Known adverse reaction to HMG-CoA reductase inhibitors
4. Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit)
5. Creatinine \>200 µmol/L
6. Known intolerance to statins or history of muscle toxicity with statins
7. Known intolerance to any of the excipients in Lipistad
8. Treatment with anti-viral medicine (glecaprevir/pibrentasvir) for hepatitis

Where it's running

  • Odense University Hospital
    Odense, Denmark     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.