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Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of Statins

NCT05062239 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-04-23

No results posted yet for this study

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 investigate the risk of POAF, infection or other complications after SAVR in continuous versus preoperative discontinuous treatment with statins.

The study is a single centre randomized controlled trial with continuance treatment with statin vs. discontinuance (7 to 14 days prior surgery until the 30th post-operative day included), on patients undergoing elective solitary SAVR with bioprosthesis with prior usage of statins the last 3 months and of at least 7 days.

This randomized studies will address 2 separate hypotheses in patients undergoing open heart operation with solitary aortic valve replacement with a bioprosthetic valve that

1. Discontinuation of HMG-CoA reductase inhibitors 7 to 14 days preoperative until 30 days postoperative of AVR in patients with prior use of HMG-CoA reductase inhibitors is not associated with increased early (\<30 days) risk of POAF.
2. Discontinuation of HMG-CoA reductase inhibitors 7 to 14 days preoperative until 30 days postoperative of AVR in patients with prior use of HMG-CoA reductase inhibitors is not associated with increased early (\<30 days) and intermediate (\<1 year) risk of mortality, MI, stroke and rehospitalisation.

Conditions

  • Postoperative Atrial Fibrillation

Interventions

DRUG

Discontinuance of treatment with statins 7 to 14 days prior to surgery until 30 days postoperative

Discontinuance of prior statin therapy

DRUG

No-intervention.

Continuance of prior statin therapy

Sponsors & Collaborators

  • Odense Patient Data Explorative Network

    collaborator OTHER

  • GCP-unit at Odense University Hospital

    collaborator UNKNOWN

  • Lars Peter Riber

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2027-02-01
Completion
2027-02-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05062239 on ClinicalTrials.gov