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

NCT05062239 | Recruiting

• 2 other identifiers: STARC210421_32021-002210-13
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Outcome Measures

Primary Outcomes (3)

• Number of Participants with POAF - In-hospital

  In-hospital POAF assessed by Holter monitoring.

  In-hospital up to 10 days.

• Number of Participants with POAF - Early

  Early assessed by anamnesis and electronic health record (EHR).

  Early (≤30 days) incidence of POAF

• Duration of POAF in-hospital

  Duration of POAF monitered with continuous ECG monitoring (eight-- lead ward monitor) up to 24 weeks.

  In-hospital

Secondary Outcomes (22)

• Number of Participants with NOAF

  Intermediate (1 year) incidence of NOAF

• Rate of all-cause mortality - In-hospital

  In-hospital up to 10 days.

• Rate of all-cause mortality - Early

  Early (≤30 days)

• Rate of all-cause mortality - intermediate

  Intermediate (1 year)

• Myocardial injury - Tn

  After surgery until discharge up to 10 days

Study Arms (2)

Continuance

ACTIVE COMPARATOR

Continuance prior statin therapy.

Drug: No-intervention.

Discontinuance

EXPERIMENTAL

Discontinuance prior statin therapy. Duration: From 7 to 14 days prior to surgery until 30 days postoperative

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

Interventions

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

Discontinuance of prior statin therapy

Discontinuance

No-intervention. DRUG

Continuance of prior statin therapy

Continuance

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• In treatment with HMG-CoA reductase inhibitors in the past 3 months and of at least 7 days
• Age \>60 years
• Willingness and provision of informed consent to be randomized

You may not qualify if:

• Prior history of atrial fibrillation
• Prior history of cardiac surgery
• Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit)
• Creatinine \>200 µmol/L

Sponsors & Collaborators

• Lars Peter Riber: lead
• Odense Patient Data Explorative Network: collaborator
• GCP-unit at Odense University Hospital: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

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MeSH Terms

Interventions

Postoperative Period

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Lytfi Krasniqi, MD

CONTACT

+4542772085; Lytfi.krasniqi@rsyd.dk

Lars Riber, MD

CONTACT

21450354; lars.riber@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Associate Professor, Ph.D., DMSc

Model Details: Discontinuous of statin Intervention: Discontinuous of statin, n = 50 Length of preoperative discontinuous: 7 to 14 days prior to surgery Length of postoperative discontinuous: 30 days Control group: continuing medication, n = 50 No withdrawal study could be found in the literature. We therefore estimate that 100 patients with 50 patients in each group will be enough to observe significant differences, if withdrawal statin should be a clinically manifested issue for the risk of POAF from 36% to 66%. Sample size Continuance of statins: 50 Discontinuance of statins: 50

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 30, 2021
• Study Start: April 1, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: TBA
• Access Criteria: TBA

Locations

DK (1)