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Clinical Trials/CTIS2024-511601-34-00
CTIS2024-511601-34-00
Recruiting
Phase 1

Post-Operative Atrial Fibrillation after Surgical Aortic Valve Replacementand the influence of HMG-CoA reductase inhibitors - STARC210421

Odense University Hospital0 sites366 target enrollmentFebruary 27, 2024

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients undergoing surgical aortic valve replacement.
Sponsor
Odense University Hospital
Enrollment
366
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 27, 2024
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Trial 1: 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 statin 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. Trial 2: 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; In treatment with statin in the past 3 months and of at least 7 days Age \>60 years; Willingness and provision of informed consent to be randomized.

Exclusion Criteria

  • Prior history of atrial fibrillation; Prior history of cardiac surgery; Known adverse reaction to statin; Hepatic dysfunction (Alanin\-aminotransferase more than twice the upper limit); Creatinine \>200 µmol/L; Known intolerance to statins or history of muscle toxicity with statins.

Outcomes

Primary Outcomes

Not specified

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