BridgeMD
New treatment option for Postoperative Atrial Fibrillation
Official title Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement
ClinicalTrials.gov ID: NCT05076019
What this study is testing
What is Atorvastatin 80mg?
Atorvastatin 80mg is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for postoperative atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 95
You may be able to join if
- 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
- Willingness and provision of informed consent to be assigned by chance
You likely can't join if
- 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)
- Creatinine \>200 µmol/L
- Known intolerance to statins or history of muscle toxicity with statins
See the full eligibility criteria
- 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
- Willingness and provision of informed consent to be assigned by chance
- 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)
- Creatinine \>200 µmol/L
- Known intolerance to statins or history of muscle toxicity with statins
- Known intolerance to any of the excipients in Lipistad
- Treatment with anti-viral medicine (glecaprevir/pibrentasvir) for hepatitis
The study team makes the final eligibility decision.
Where it's taking place
- Odense, Denmark
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, 60 years to 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.