Actively Recruiting
Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement
Led by Odense University Hospital · Updated on 2024-10-08
266
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
O
Odense Patient Data Explorative Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing elective solitary SAVR with bioprosthesis
- Patients in sinus rhythm and not taking anti-arrhythmic medications other than beta-blockers at surgery time
- No prior use of HMG-CoA reductase inhibitors in the last 3 months and at least 7 days before surgery
- Age greater than 60 years
- Willingness and ability to provide informed consent for randomization
You will not qualify if you...
- Prior history of atrial fibrillation
- Prior history of cardiac surgery
- Known adverse reaction to HMG-CoA reductase inhibitors
- Hepatic dysfunction with Alanin-aminotransferase more than twice the upper limit
- Creatinine levels greater than 200 µmol/L
- Known intolerance to statins or history of muscle toxicity with statins
- Known intolerance to any excipients in Lipistad
- Treatment with anti-viral medicine (glecaprevir/pibrentasvir) for hepatitis
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Trial Site Locations
Total: 1 location
1
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
Research Team
L
Lytfi Krasniqi, MD
CONTACT
L
Lars Peter Riber, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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