Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Postoperative Atrial Fibrillation

In brief

Statins have rapid and significant actions that have potentially important (but not yet proven) implications for postoperative atrial fibrillation and cardiac protection in patients undergoing cardiac surgery. The focus of this study is, therefore, on patients having surgical aortic valve replacement (with aortotomy) and the development of postoperative atrial fibrillation (POAF). Our aims are: to examine the ability of a clinically durable Atorvastatin prophylactic regime to prevent the development of POAF and other postoperative complications in these patients. Patients will be randomized to Atorvastatin 80mg or placebo 7 to 14 days preoperative until 30 days postoperative - a total of 37 to 44 days of treatment. The medication will be double blinded. The randomized studie will address the following hypotheses in patients undergoing open heart operation with solitary aortic valve replacement with a bioprosthetic valve that 1\) 7 to 14 days preoperative and until 30 days postoperative treatment with Atorvastatin 80 mg daily reduces the incidence of POAF in statin-naïve patients.

Key facts

Study ID: NCT05076019
Run by: Odense University Hospital
People needed: 266
Starts: 2022-02-01
Expected to finish: 2027-12-01
Last updated by the study team: 2024-10-08

Who can join

Age: 60 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Odense University Hospital — Odense, Denmark (enrolling)

Full record on ClinicalTrials.gov

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