Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Number of Participants with POAF - Early
研究概览
简要总结
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
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 60 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Atorvastatin 80 mg
Dosage: 80 mg Form: Tablets Frequency: 1 tabl. per day. Duration: From 7 to 14 days prior to surgery until 30 days postoperative
干预措施: Atorvastatin 80mg (Drug)
Placebo
Form: Tablets Frequency: 1 tabl. per day. Duration: From 7 to 14 days prior to surgery until 30 days postoperative
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with POAF - Early
时间窗: Early (≤30 days) incidence of POAF
Early assessed by anamnesis, electronic health record (EHR), or confirmatory rhythm strip or 12-lead ECG of AF
Number of Participants with POAF - In-hospital
时间窗: In-hospital up to 10 days
In-hospital incidence of POAF assessed by continuous ECG monitoring (8-lead ward monitor).
Total duration of POAF - In-hospital
时间窗: In-hospital up to 10 days
Total duration of POAF episodes experienced in-hospital (unit: hours)
次要结局
- Stroke - Intermediate(Intermediate (1 year))
- Trans ischemic attack - Intermediate(Intermediate (1 year))
- TAPSE(Before surgery compared with prior to discharge (On the 3rd to 5th postoperative day).)
- Length of stay on ICU(Day of surgery to the day of discharge from ICU. Up to 52 weeks.)
- Rate of All-cause mortality - In-hospital(In hospital up to 10 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.)
- Stroke - Early(Early (≤30 days))
- Myocardial infarction - Intermediate(Intermediate (1 year))
- Permanent pacemaker - Intermediate(Intermediate (1 year))
- Mean gradient(Before surgery compared with prior to discharge (On the 3rd to 5th postoperative day).)
- Permanent pacemaker - Early(Early (≤30 days))
- ICD implantation - Early(Early (≤30 days))
- ICD implantation - Intermediate(Intermediate (1 year))
- Acute kidney injury - Early(Early (≤30 days))
- Rate of All-cause mortality - Early(Early (≤30 days))
- Trans ischemic attack - Early(Early (≤30 days))
- Strain(Before surgery compared with prior to discharge (On the 3rd to 5th postoperative day).)
- Peak gradient(Before surgery compared with prior to discharge (On the 3rd to 5th postoperative day).)
- Myocardial infarction - Early(Early (≤30 days))
- Acute kidney injury - Intermediate(Intermediate (1 year))
- LVEF(Before surgery compared with prior to discharge (On the 3rd to 5th postoperative day).)
- Length of stay in hospital(Day of surgery to the day of discharge. Up to 52 weeks.)
研究者
Lars Peter Riber
MD, Associate Professor, Ph.D., DMSc
Odense University Hospital