Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement
Status:
Not yet recruiting
Trial end date:
2027-02-01
Target enrollment:
Participant gender:
Summary
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 3 separate 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.
2. 7 to 14 days preoperative and until 30 days postoperative treatment with Atorvastatin 80
mg daily reduce early (<30 days) and intermediate (<1 year) mortality, MI, stroke and
rehospitalisation in statin-naïve patients.
3. Atorvastatin 80 mg daily reduces the myocardial injury and inflammatory response and
improves cardiac and renal function in statin-naïve patients.
Phase:
N/A
Details
Lead Sponsor:
Odense University Hospital
Collaborators:
GCP-unit at Odense University Hospital Odense Patient Data Explorative Network