Atorvastatin Compared With Placebo After Aortic Valve Replacement Surgery
Tests atorvastatin against placebo in adults having aortic valve surgery.
Plain-language title generated from the registry record
Registry title: Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement
Key facts
- Where
- Odense, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 95 years old?
Source: NCT05076019, who can take part
Where in Denmark
- Odense University HospitalOdense, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Odense University Hospital
- Trial code
- NCT05076019
- Record updated
- 8 October 2024
- Original description
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.Read full original descriptionShow less
Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement - a Randomized Controlled 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.
Inclusion: 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.
Exclusion: Prior history of atrial fibrillation; Prior history of cardiac surgery; Known adverse reaction to HMG-CoA reductase inhibitors; Treatment with anti-viral medicine (glecaprevir/pibrentasvir) for hepatitis; Known intolerance to statins or history of muscle toxicity with statins; Creatinine >200 µmol/L; Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit); Known intolerance to any of the excipients in Lipistad.