Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement
ConditionPostoperative Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-95
SponsorOdense University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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 HMG-CoA reductase inhibitors the last 3 months and at least 7 days prior to the time of surgery
Age >60 years
Disqualifiers
Prior history of atrial fibrillation
Prior history of cardiac surgery
Known adverse reaction to HMG-CoA reductase inhibitors
Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit)
Trial design
Design model
Parallel
Treatments tested in this trial
Atorvastatin 80mg
DrugDosage: 80 mg Form: Tablets Frequency: 1 tabl. per day. Duration: From 7 to 14 days prior to surgery until 30 days postoperative
Placebo
DrugForm: Tablets Frequency: 1 tabl. per day. Duration: From 7 to 14 days prior to surgery until 30 days postoperative
Treatment groups
266 Participants
are divided into 2 treatment groupsGroup A: Atorvastatin 80 mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with POAF - In-hospital
In-hospital incidence of POAF assessed by continuous ECG monitoring (8-lead ward monitor).
Time frame
In-hospital up to 10 days2
Number of Participants with POAF - Early
Early assessed by anamnesis, electronic health record (EHR), or confirmatory rhythm strip or 12-lead ECG of AF
Time frame
Early (≤30 days) incidence of POAF3
Total duration of POAF - In-hospital
Total duration of POAF episodes experienced in-hospital (unit: hours)
Time frame
In-hospital up to 10 daysSecondary outcomes
1
Rate of All-cause mortality - In-hospital
To evaluate the effect of prophylactic regime administration of Atorvastatin on clinical outcomes. Number of deaths in each group.
Time frame
In hospital up to 10 days2
Rate of All-cause mortality - Early
To evaluate the effect of prophylactic regime administration of Atorvastatin on clinical outcomes. Number of deaths in each group.
Time frame
Early (≤30 days)3
Rate of All-cause mortality - intermediate
To evaluate the effect of prophylactic regime administration of Atorvastatin on clinical outcomes. Number of deaths in each group.
Time frame
intermediate (1 year)4
Myocardial injury - Tn
Injury assessed by serial Troponin measurements. Unit:ng/l
Time frame
After surgery until discharge up to 10 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Odense University Hospital
Lead sponsor
Odense Patient Data Explorative Network
Collaborator
GCP-unit at Odense University Hospital
Collaborator
Source ClinicalTrials.gov