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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511601-34-00
Acronym
STARC210421
Enrollment
366
Registered
2024-03-21
Start date
2022-03-19
Completion date
Unknown
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing surgical aortic valve replacement.

Brief summary

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.

Detailed description

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

Interventions

DRUGATORVASTATIN
DRUGLactose monohydrate 307
DRUG5mg
DRUGPatato starch 310
DRUG0mg
DRUGGelatine 6
DRUG4mg
DRUGMagnesium stearate 3
DRUG25mg
DRUGTalc 29

Sponsors

Odense University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026