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RECRUITING
NCT05076019
NA

Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement

Sponsor: Odense University Hospital

View on ClinicalTrials.gov

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.

Official title: Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement - a Randomized Controlled Trial

Key Details

Gender

All

Age Range

60 Years - 95 Years

Study Type

INTERVENTIONAL

Enrollment

266

Start Date

2022-02-01

Completion Date

2027-12-01

Last Updated

2024-10-08

Healthy Volunteers

No

Interventions

DRUG

Atorvastatin 80mg

Dosage: 80 mg Form: Tablets Frequency: 1 tabl. per day. Duration: From 7 to 14 days prior to surgery until 30 days postoperative

DRUG

Placebo

Form: Tablets Frequency: 1 tabl. per day. Duration: From 7 to 14 days prior to surgery until 30 days postoperative

Locations (1)

Odense University Hospital

Odense, Denmark