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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05076019
Other study ID # STARC210421_2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date December 1, 2027

Study information

Verified date April 2023
Source Odense University Hospital
Contact Lytfi Krasniqi, MD
Phone 42772085
Email Lytfi.krasniqi@rsyd.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Trial Participants: Enrolment for the study is planned to start February 2022 and continue until 266 patients have been enrolled. DEFINITION OF POAF: Postoperative AF (I48) is defined as irregular RR-intervals without a traceable p-wave before each QRS complex during at least 30 seconds or entire 12-lead ECG in symptomatic or asymptomatic patients with no prior history of atrial fibrillation or flutter are considered4. Continuous ECG monitoring (8-lead ward monitor) will recognise AF during the entire hospitalization. Anamnesis, electronic health record (EHR), or confirmatory rhythm strip or 12-lead ECG of AF until 30th postoperative day are also considered. We will also report the burden of atrial fibrillation, and treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion. Course of action: Patients undergoing elective surgical aortic valve replacement with bioprosthesis at the Department of Cardiac Surgery at Odense University Hospital will be offered participation in the study. Potentially eligible patients will be screened according to inclusion/exclusion criteria at the time after eligibility of surgery. This is assessed at a multidisciplinary team (MDT) conference (with attendance of cardiologist, cardiac surgeons and anaesthesiologist) based on clinical evaluation, echocardiographic ultrasound, coronary angiography and lung function test. Patients eligible to participate in the study will be presented with the information of the study at the time of their out-patient appointment, according to normal routine at Odense University Hospital. At this appointment the patient receives a physical examination and journal record is obtained by a cardiac surgeon (approximately 7 to 14 days prior to planned surgery). The study-information will be given by one of the participating doctors, while the patient has been informed of the possibility of bringing an assessor of their choice. The information will be delivered in a quiet room blocked to other appointments in the Department of Cardiothoracic Surgery. During this meeting the patient will be informed of the purpose of this study and the written patient information will be submitted in detail. Patients will be given as much time as wanted after the oral information has been delivered to decide if they wish to participate in the study. Patients will be offered the possibility to call one of the doctors taking part in this study during this time, in case of additional questions. Subjects can leave the study at any time for any reason if they wish to do so, without any consequences. Signed informed consent will be provided prior to any research procedures. A subject is registered when signed informed consent has been provided and assigned a subject identification code by the computer-generated code. A subject is randomized when a treatment and a randomisation number has been provided. A subject is considered enrolled in the study once the subject is randomized. Patient data from EHR will be conducted according to study endpoints after signed informed consent is provided. Signed consent gives sponsor and sponsors representatives Randomization: Allocation to a numbered treatment pack (Atorvastatin or placebo - blinded) Randomization scheme will be set-up by OPEN data manager with control for beta-blockers and age, and then randomization per se will be executed with the use of REDCap. The following will be recorded at the day of randomization: - Conduct information for baseline characteristics - Transthoracic Echocardiography measurements Collect baseline blood sample: • Troponin, CK-MB, Creatinine, CRP Commence study medication/treatment Perioperative interventions and outcomes from the day of surgery to the day of discharge: - Duration of aortic cross clamp (ACC), extracorporeal circulation (ECC), ventilatory support, intensive care unit stay period, hospital stay period - Continue study medication - Blood samples: - Preoperative: Troponin, CK-MB, Creatinine, CRP, Plasma-Atorvastatin - Serial troponin and CK-MB levels: (6, 24, 48, and 96 hours after surgery). - Creatinine levels: 48 and 96 hours after surgery. - CRP levels: 48 and 96 hours after surgery - Monitor ECG by continuous Holter monitoring to commence as soon as possible after surgery and continue up to post-operative day 5 evening - Transthoracic Echocardiography on post-operative day 3-5 - Record fluid intake and output during the first 48 hours following surgery based on IV fluids administration, blood transfusion (if applicable), oral/nasogastric intake, and urine plus surgical drain output - Record intraoperative defibrillation, removal of external pacemaker, new PPM/ICD, vasopressors, blood transfusion, surgical re-exploration, renal replacement therapy, beta-blockers, ACEi/ARB, Amiodarone, Digoxin, Diuretics, Calcium channel blockers, Potassium supplements, NSAIDs or steroids, non-study statin, use of nephrotoxic antibiotics, contrast agents or potassium sparing diuretics (Yes/No) Assessment at/after discharge from hospital: - Continue study medications for 30 days after the surgery - Phone call on the 30th postoperative day to evaluate symptoms of discomfort compatible with atrial fibrillation - At the end of the study, all excess study medication can be returned at the local drugstore for safe disposal - Patient data from EHR will be conducted according to study endpoints.


Recruitment information / eligibility

Status Recruiting
Enrollment 266
Est. completion date December 1, 2027
Est. primary completion date December 1, 2027
Accepts healthy volunteers No
Gender All
Age group 60 Years to 95 Years
Eligibility Inclusion Criteria: 1. Patients undergoing elective solitary SAVR with bioprosthesis 2. Patients who are in sinus rhythm and not taking any anti-arrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery 3. No prior use of HMG-CoA reductase inhibitors the last 3 months and at least 7 days prior to the time of surgery 4. Age >60 years 5. Willingness and provision of informed consent to be randomized Exclusion Criteria: 1. Prior history of atrial fibrillation 2. Prior history of cardiac surgery 3. Known adverse reaction to HMG-CoA reductase inhibitors 4. Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit) 5. Creatinine >200 µmol/L 6. Known intolerance to statins or history of muscle toxicity with statins 7. Known intolerance to any of the excipients in Lipistad 8. Treatment with anti-viral medicine (glecaprevir/pibrentasvir) for hepatitis

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark Odense University Hospital Odense

Sponsors (3)

Lead Sponsor Collaborator
Odense University Hospital GCP-unit at Odense University Hospital, Odense Patient Data Explorative Network

Country where clinical trial is conducted

Denmark, 

References & Publications (47)

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Crystal E, Connolly SJ, Sleik K, Ginger TJ, Yusuf S. Interventions on prevention of postoperative atrial fibrillation in patients undergoing heart surgery: a meta-analysis. Circulation. 2002 Jul 2;106(1):75-80. doi: 10.1161/01.cir.0000021113.44111.3e. — View Citation

Davignon J. Beneficial cardiovascular pleiotropic effects of statins. Circulation. 2004 Jun 15;109(23 Suppl 1):III39-43. doi: 10.1161/01.CIR.0000131517.20177.5a. — View Citation

Dobrev D, Aguilar M, Heijman J, Guichard JB, Nattel S. Postoperative atrial fibrillation: mechanisms, manifestations and management. Nat Rev Cardiol. 2019 Jul;16(7):417-436. doi: 10.1038/s41569-019-0166-5. — View Citation

Fang WT, Li HJ, Zhang H, Jiang S. The role of statin therapy in the prevention of atrial fibrillation: a meta-analysis of randomized controlled trials. Br J Clin Pharmacol. 2012 Nov;74(5):744-56. doi: 10.1111/j.1365-2125.2012.04258.x. — View Citation

Fauchier L, Clementy N, Babuty D. Statin therapy and atrial fibrillation: systematic review and updated meta-analysis of published randomized controlled trials. Curr Opin Cardiol. 2013 Jan;28(1):7-18. doi: 10.1097/HCO.0b013e32835b0956. — View Citation

Fragao-Marques M, Mancio J, Oliveira J, Falcao-Pires I, Leite-Moreira A. Gender Differences in Predictors and Long-Term Mortality of New-Onset Postoperative Atrial Fibrillation Following Isolated Aortic Valve Replacement Surgery. Ann Thorac Cardiovasc Surg. 2020 Dec 20;26(6):342-351. doi: 10.5761/atcs.oa.19-00314. Epub 2020 Apr 28. — View Citation

Greenberg JW, Lancaster TS, Schuessler RB, Melby SJ. Postoperative atrial fibrillation following cardiac surgery: a persistent complication. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):665-672. doi: 10.1093/ejcts/ezx039. — View Citation

Halonen J, Halonen P, Jarvinen O, Taskinen P, Auvinen T, Tarkka M, Hippelainen M, Juvonen T, Hartikainen J, Hakala T. Corticosteroids for the prevention of atrial fibrillation after cardiac surgery: a randomized controlled trial. JAMA. 2007 Apr 11;297(14):1562-7. doi: 10.1001/jama.297.14.1562. — View Citation

Hansen MR, Hrobjartsson A, Pottegard A, Damkier P, Madsen KG, Pareek M, Olesen M, Hallas J. Postponement of cardiovascular outcomes by statin use: A systematic review and meta-analysis of randomized clinical trials. Basic Clin Pharmacol Toxicol. 2021 Feb;128(2):286-296. doi: 10.1111/bcpt.13485. Epub 2020 Oct 8. — View Citation

Hashemzadeh K, Dehdilani M, Dehdilani M. Postoperative Atrial Fibrillation following Open Cardiac Surgery: Predisposing Factors and Complications. J Cardiovasc Thorac Res. 2013;5(3):101-7. doi: 10.5681/jcvtr.2013.022. Epub 2013 Oct 5. — View Citation

Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available. Erratum In: Eur Heart J. 2021 Feb 1;42(5):507. Eur Heart J. 2021 Feb 1;42(5):546-547. Eur Heart J. 2021 Oct 21;42(40):4194. — View Citation

Ji Q, Mei Y, Wang X, Sun Y, Feng J, Cai J, Xie S, Chi L. Effect of preoperative atorvastatin therapy on atrial fibrillation following off-pump coronary artery bypass grafting. Circ J. 2009 Dec;73(12):2244-9. doi: 10.1253/circj.cj-09-0352. Epub 2009 Oct 13. — View Citation

Kim YM, Kattach H, Ratnatunga C, Pillai R, Channon KM, Casadei B. Association of atrial nicotinamide adenine dinucleotide phosphate oxidase activity with the development of atrial fibrillation after cardiac surgery. J Am Coll Cardiol. 2008 Jan 1;51(1):68-74. doi: 10.1016/j.jacc.2007.07.085. — View Citation

Kuhn EW, Liakopoulos OJ, Stange S, Deppe AC, Slottosch I, Choi YH, Wahlers T. Preoperative statin therapy in cardiac surgery: a meta-analysis of 90,000 patients. Eur J Cardiothorac Surg. 2014 Jan;45(1):17-26; discussion 26. doi: 10.1093/ejcts/ezt181. Epub 2013 Apr 5. — View Citation

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LaPar DJ, Crosby IK, Rich JB, Fonner E Jr, Kron IL, Ailawadi G, Speir AM; Investigators for Virginia Cardiac Surgery Quality Initiative. A contemporary cost analysis of postoperative morbidity after coronary artery bypass grafting with and without concomitant aortic valve replacement to improve patient quality and cost-effective care. Ann Thorac Surg. 2013 Nov;96(5):1621-7. doi: 10.1016/j.athoracsur.2013.05.050. Epub 2013 Aug 21. — View Citation

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* Note: There are 47 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Total duration of POAF - In-hospital Total duration of POAF episodes experienced in-hospital (unit: hours) In-hospital up to 10 days
Secondary Rate of All-cause mortality - In-hospital To evaluate the effect of prophylactic regime administration of Atorvastatin on clinical outcomes.
Number of deaths in each group.
In hospital up to 10 days
Secondary Rate of All-cause mortality - Early To evaluate the effect of prophylactic regime administration of Atorvastatin on clinical outcomes.
Number of deaths in each group.
Early (=30 days)
Secondary Rate of All-cause mortality - intermediate To evaluate the effect of prophylactic regime administration of Atorvastatin on clinical outcomes.
Number of deaths in each group.
intermediate (1 year)
Secondary Myocardial injury - Tn Injury assessed by serial Troponin measurements. Unit:ng/l After surgery until discharge up to 10 days.
Secondary Myocardial injury - CKMB Injury assessed by serial CKMB measurements. Unit: µg/l. After surgery until discharge up to 10 days.
Secondary Stroke - Early Number of patients with stroke in each group. Early (=30 days)
Secondary Stroke - Intermediate Number of patients with stroke in each group. Intermediate (1 year)
Secondary Trans ischemic attack - Early Number of patients with trans ischemic attack in each group. Early (=30 days)
Secondary Trans ischemic attack - Intermediate Number of patients with trans ischemic attack in each group. Intermediate (1 year)
Secondary Myocardial infarction - Early Number of patients with Myocardial infarction in each group. Early (=30 days)
Secondary Myocardial infarction - Intermediate Number of patients with Myocardial infarction in each group. Intermediate (1 year)
Secondary Permanent pacemaker - Early Number of patients with Permanent pacemaker in each group. Early (=30 days)
Secondary Permanent pacemaker - Intermediate Number of patients with Permanent pacemaker in each group. Intermediate (1 year)
Secondary ICD implantation - Early Number of patients with ICD implantation in each group. Early (=30 days)
Secondary ICD implantation - Intermediate Number of patients with ICD implantation in each group. Intermediate (1 year)
Secondary Acute kidney injury - Early Number of patients with Acute kidney injury in each group. Early (=30 days)
Secondary Acute kidney injury - Intermediate Number of patients with Acute kidney injury in each group. Intermediate (1 year)
Secondary LVEF Describe echocardiography assessed differences in pre and postoperative measurements of LVEF(left ventricular ejection fraction) between groups. Unit: % Before surgery compared with prior to discharge (On the 3rd to 5th postoperative day).
Secondary Strain Describe echocardiography assessed differences in pre and postoperative measurements of Strain between groups.Unit: % Before surgery compared with prior to discharge (On the 3rd to 5th postoperative day).
Secondary Peak gradient Describe echocardiography assessed differences in pre and postoperative measurements of peak gradient between groups. Unit: mmHg Before surgery compared with prior to discharge (On the 3rd to 5th postoperative day).
Secondary Mean gradient Describe echocardiography assessed differences in pre and postoperative measurements of mean gradient between groups. Unit: mmHg Before surgery compared with prior to discharge (On the 3rd to 5th postoperative day).
Secondary TAPSE Describe echocardiography assessed differences in pre and postoperative measurements of TAPSE (tricuspid annular plane systolic excursion) between groups. Unit: mm Before surgery compared with prior to discharge (On the 3rd to 5th postoperative day).
Secondary Length of stay on ICU Length of stay on ICU after surgery. Unit: Days Day of surgery to the day of discharge from ICU. Up to 52 weeks.
Secondary Length of stay in hospital Length of stay in hospital after surgery. Unit: Days Day of surgery to the day of discharge. Up to 52 weeks.
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