Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement

NCT05076019 | Recruiting DMC

• 1 other identifier: STARC210421_2
• Study Type: interventional
• Target: 266
• 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 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.

Conditions

Postoperative Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Number of Participants with POAF - In-hospital

  In-hospital incidence of POAF assessed by continuous ECG monitoring (8-lead ward monitor).

  In-hospital up to 10 days

• Number of Participants with POAF - Early

  Early assessed by anamnesis, electronic health record (EHR), or confirmatory rhythm strip or 12-lead ECG of AF

  Early (≤30 days) incidence of POAF

• Total duration of POAF - In-hospital

  Total duration of POAF episodes experienced in-hospital (unit: hours)

  In-hospital up to 10 days

Secondary Outcomes (24)

• 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.

• Myocardial injury - CKMB

  After surgery until discharge up to 10 days.

Study Arms (2)

Atorvastatin 80 mg

EXPERIMENTAL

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

Drug: Atorvastatin 80mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Atorvastatin 80mg DRUG

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

Atorvastatin 80 mg

Placebo DRUG

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

Placebo

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
• No prior use of HMG-CoA reductase inhibitors 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

You may not qualify if:

• Prior history of atrial fibrillation
• Prior history of cardiac surgery
• Known adverse reaction to HMG-CoA reductase inhibitors
• 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
• Known intolerance to any of the excipients in Lipistad
• Treatment with anti-viral medicine (glecaprevir/pibrentasvir) for hepatitis

Sponsors & Collaborators

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

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Related Publications (48)

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MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

Lytfi Krasniqi, MD

CONTACT

42772085; Lytfi.krasniqi@rsyd.dk

Lars Peter Riber, MD

CONTACT

21450354; lars.riber@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A unique identifier (code) will be generated for all patients to allow for data management. The list of patients enrolled in the study is available to the data and safety monitoring board. Patients, physicians, nurses, and other data collectors are kept blinded to the allocation during the study. The study medication is allocated in identical non-transparent containers. The placebo resembles the study drug for taste, smell, color, and shape. Hospital pharmacy will be responsible for packaging the medicine, blinding and create sealed code envelopes in case of urgent need for unblinding. The unblinding of study 2 is planned to take place when the last patients has been followed for at least 30 days and early data analysis have been statistically treated while data is still blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor, Ph.D., DMSc

Model Details: Intervention: Atorvastatin, n = 133 Dose: 80 mg/daily P.O. Length of preoperative statin exposure: 7 to 14 days prior to surgery Length of postoperative exposure: 30 days Control group: Placebo, n = 133 Study parameters Incidence, placebo group: 36% Incidence, Atorvastatin group: 20% Alpha: 0.05 Beta: 0.2 Power: 0.8 Enrolment ratio: 1:1 Sample size Placebo: 133 Atorvastatin: 133

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: October 13, 2021
• Study Start: February 1, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

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

Locations

DK (1)