ATORVASTATIN for Post-operative atrial fibrillation | Atrial fibrillation | Surgical aortic valve replacement

Inclusion criteria

• {"criterion_text":"- Trial 1: Patients undergoing elective solitary SAVR with bioprosthesis;\n- Patients who are in sinus rhythm and not taking any anti-arrhythmic medication; other than beta-adrenergic blocking agents; at the time of surgery;\n- No prior use of statin the last 3 months and at least 7 days prior to the time of surgery Age >60 years;\n- Willingness and provision of informed consent to be randomized.\n- Trial 2: Patients undergoing elective solitary SAVR with bioprosthesis;\n- Patients who are in sinus rhythm and not taking any anti-arrhythmic medication other than beta-adrenergic blocking agents, at the time of surgery;\n- In treatment with statin in the past 3 months and of at least 7 days Age >60 years;\n- Willingness and provision of informed consent to be randomized."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- 1. Number of Participants with POAF - In-hospital;\n- 2. Number of Participants with POAF within 30 days.\n- 3. Number of Participants with AFIB within 1 year.","definition_or_measurement_approach":"Primary endpoints assessed by Holter monitoring, in-hospital assessment and follow-up visits/clinical records for 30 days and up to 1 year as stated in objectives."}

Secondary endpoints

• {"endpoint_text":"- 4) Rate of All-cause mortality\n- 7) Myocardial injury - TnT\n- 8) Myocardial injury - CKMB\n- 9) Stroke - Early\n- 10) Stroke - Intermediate\n- 11) Trans ischemic attack\n- 13) Myocardial infarction\n- 15) Permanent pacemaker\n- 17) ICD implantation\n- 19) Acute kidney injury\n- 21) Left ventricular ejection fraction\n- 22) Strain\n- 23) Peak gradient\n- 24) Mean gradient\n- 25) TAPSE\n- 26) Length of stay on ICU\n- 27) Length of stay in hospital","definition_or_measurement_approach":"Measured as reported in clinical records and study assessments: all-cause mortality by clinical records; myocardial injury by biochemical markers (TnT, CK-MB); stroke/TIA and myocardial infarction by clinical diagnosis and standard criteria; device implantations (pacemaker/ICD) by procedure records; acute kidney injury by creatinine and lab criteria; LVEF, strain, peak/mean gradient, TAPSE by echocardiography; lengths of stay from hospital/ICU records."}

Denmark

Earliest CTIS Part Ii Submission Date

16-03-2024

Latest Decision Or Authorization Date

21-03-2024

Processing Time Days

5

Number Of Sites

1

Number Of Participants

366

Primary sponsor

Full Name

Odense University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsorDuties codes: 1, 7, 8","organisation_type":"Hospital/Clinic/Other health care facility"}