Post-Operative Atrial Fibrillation after Surgical Aortic Valve Replacement and the influence of HMG-CoA reductase inhibitors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Odense University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

19 Mar 2022 → ongoing

Decision date (initial)

2024-03-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-511601-34-00

EudraCT number

2021-002210-13

ClinicalTrials.gov

NCT05076019

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

Trial NCT05062239:
The primary objective of this study is to establish if prophylactic regime administration of Atorvastatin 80 mg daily dose P.O. (started at least 7 to 14 days before surgery and continued until the 30th post-operative day included) in patients undergoing elective solitary SAVR with bioprosthesis and are statin-naïve leads to a reduction in the incidence of POAF evaluated by Holter monitoring.

Trial NCT05062239:
The primary objective of study 3 is to investigate if discontinuance of statins in patients undergoing elective solitary SAVR with bioprosthesis with prior usage of statin the last 3 months and of at least 7 days is associated with risk of POAF or other complications including infections evaluated by Holter monitoring, clinical presentation and biochemical parameters.

Secondary objectives 1

1. The secondary objectives are to evaluate if statins affects early (≤30 days) and intermediate (1 year) clinical outcomes, echocardiographic outcomes, length of hospital care or the need of readmission.

Conditions and MedDRA coding

Patients undergoing surgical aortic valve replacement.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Trial 1: 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 statin 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. Trial 2: 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 statin in the past 3 months and of at least 7 days Age >60 years; Willingness and provision of informed consent to be randomized.

Exclusion criteria 1

1. Prior history of atrial fibrillation; Prior history of cardiac surgery; Known adverse reaction to statin; Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit); Creatinine >200 μmol/L; Known intolerance to statins or history of muscle toxicity with statins.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Number of Participants with POAF - In-hospital; 2. Number of Participants with POAF within 30 days. 3. Number of Participants with AFIB within 1 year.

Secondary endpoints 1

1. 4) Rate of All-cause mortality 7) Myocardial injury - TnT 8) Myocardial injury - CKMB 9) Stroke - Early 10) Stroke - Intermediate 11) Trans ischemic attack 13) Myocardial infarction 15) Permanent pacemaker 17) ICD implantation 19) Acute kidney injury 21) Left ventricular ejection fraction 22) Strain 23) Peak gradient 24) Mean gradient 25) TAPSE 26) Length of stay on ICU 27) Length of stay in hospital

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Odense University Hospital

Sponsor organisation

Odense University Hospital

Address

J B Winsloews Vej 4

City

Odense C

Postcode

5000

Country

Denmark

Scientific contact point

Organisation

Odense University Hospital

Contact name

Lytfi Krasniqi

Public contact point

Organisation

Odense University Hospital

Contact name

Lytfi Krasniqi

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications