NCT05076019 Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement
| NCT ID | NCT05076019 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Postoperative Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 266 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 266 participants in total. It began in 2022-02-01 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Patients undergoing elective solitary SAVR with bioprosthesis 2. Patients who are in sinus rhythm and not taking any anti-arrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery 3. No prior use of HMG-CoA reductase inhibitors the last 3 months and at least 7 days prior to the time of surgery 4. Age \>60 years 5. Willingness and provision of informed consent to be randomized Exclusion Criteria: 1. Prior history of atrial fibrillation 2. Prior history of cardiac surgery 3. Known adverse reaction to HMG-CoA reductase inhibitors 4. Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit) 5. Creatinine \>200 µmol/L 6. Known intolerance to statins or history of muscle toxicity with statins 7. Known intolerance to any of the excipients in Lipistad 8. Treatment with anti-viral medicine (glecaprevir/pibrentasvir) for hepatitis
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05076019 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 95 Years, studying Postoperative Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05076019 currently recruiting?
Yes, NCT05076019 is actively recruiting participants. Contact the research team at Lytfi.krasniqi@rsyd.dk for enrollment information.
Where is the NCT05076019 trial being conducted?
This trial is being conducted at Odense, Denmark.
Who is sponsoring the NCT05076019 clinical trial?
NCT05076019 is sponsored by Odense University Hospital. The trial plans to enroll 266 participants.
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