drugset / Trial / NCT05076019
Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement
Recruiting
266 enrolled
Odense University Hospital
GCP-unit at Odense University Hospital · collabOdense Patient Data Explorative Network · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
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.
Timeline
- Start
- 2022-02-01
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 80 mg | — |