Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-95
SponsorOdense University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Atorvastatin 80mg
  • Placebo

Treatment groups

266 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Odense University Hospital

Lead sponsor

Odense Patient Data Explorative Network

Collaborator

GCP-unit at Odense University Hospital

Collaborator