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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 95
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Lytfi Krasniqi, MD
Lytfi.krasniqi@rsyd.dk
42772085
Backup
Lars Peter Riber, MD
lars.riber@rsyd.dk
21450354
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 266
Treatments
Experimental: Atorvastatin 80 mg
Dosage: 80 mg Form: Tablets Frequency: 1 tabl. per day. Duration: From 7 to 14 days prior to surgery until 30 days postoperative
Placebo_comparator: Placebo
Form: Tablets Frequency: 1 tabl. per day. Duration: From 7 to 14 days prior to surgery until 30 days postoperative
Sponsors
Leads: Odense University Hospital
Collaborators: Odense Patient Data Explorative Network, GCP-unit at Odense University Hospital

This content was sourced from clinicaltrials.gov