Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement

NCT05076019 · tracked via the Priya Life Science Denmark tracker

Sponsor

Odense University Hospital

Phase

Not applicable

Started

2022-02-01

Last updated

2024-10-08

Condition(s) studied

Postoperative Atrial Fibrillation

Investigational drug(s) / intervention(s)

Atorvastatin 80mg →Placebo

Atorvastatin 80mg: Dosage: 80 mg Form: Tablets Frequency: 1 tabl. per day. Duration: From 7 to 14 days prior to surgery until 30 days postoperative

Placebo: Form: Tablets Frequency: 1 tabl. per day. Duration: From 7 to 14 days prior to surgery until 30 days postoperative

Study 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

Sex

ALL

Min age

60 Years

Max age

95 Years

Healthy volunteers

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

Primary outcome measure(s)

Number of Participants with POAF - In-hospital — In-hospital up to 10 days
In-hospital incidence of POAF assessed by continuous ECG monitoring (8-lead ward monitor).
Number of Participants with POAF - Early — Early (≤30 days) incidence of POAF
Early assessed by anamnesis, electronic health record (EHR), or confirmatory rhythm strip or 12-lead ECG of AF
Total duration of POAF - In-hospital — In-hospital up to 10 days
Total duration of POAF episodes experienced in-hospital (unit: hours)

Trial sites (1)

Facility	City	Region	Status
Odense University Hospital	Odense	Denmark	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05076019 on ClinicalTrials.gov ↗ ← All trials in Denmark