NCT05076019Recruiting
Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement
Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement - a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 8 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 266 (estimated)
- First submitted
- 19 Aug 2021
- Start date
- 1 Feb 2022
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Odense University Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT05076019
What you commit to
- Study type: Interventional
- Planned participants: 266
- From 1 Feb 2022 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of atrial fibrillation
- Prior history of cardiac surgery
- Known adverse reaction to HMG-CoA reductase inhibitors
- Treatment with anti-viral medicine (glecaprevir/pibrentasvir) for hepatitis
Other illness
- Known intolerance to statins or history of muscle toxicity with statins
Lab values
- Creatinine \>200 µmol/L
Other
- Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit)
- Known intolerance to any of the excipients in Lipistad
Who the study is looking for
- 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 randomized
Age in the registry: 60 years to 95 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.