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Post-Operative Atrial Fibrillation after Surgical Aortic Valve Replacement and the influence of HMG-CoA reductase inhibitors
EU CTIS ID: 2024-511601-34-00
What this study is testing
Trial NCT05062239: The primary objective of this study is to establish if prophylactic regime administration of Atorvastatin 80 mg daily dose P.O. (started at least 7 to 14 days before surgery and continued until the 30th post-operative day included) in patients undergoing elective solitary SAVR with bioprosthesis and are statin-naïve leads to a reduction in the incidence of POAF evaluated by Holter monitoring. Trial NCT05062239: The primary objective of study 3 is to investigate if discontinuance of statins in patients undergoing elective solitary SAVR with bioprosthesis with prior usage of statin the last 3 months and of at least 7 days is associated with risk of POAF or other complications including infections evaluated by Holter monitoring, clinical presentation and biochemical parameters.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.