Educational Intervention for Patient's Awareness on eaRly LDL-C Lowering Using Novel Pharmacological Strategies in secondarY Prevention (EARLY)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 30
- 主要终点
- Number of patients achieving Guideline recommended LDL-Cholesterol goal
研究概览
简要总结
Cluster Randomized Trial to test the effectiveness of a patient level delivered educational intervention to improve the awareness on the relevance of obtaining LDL cholesterol recommended goals in patients admitted for an acute coronary syndrome, as compared to usual care. Overall, 24 sites (Coronary Care Units) will be included in the study, 12 randomized to the intervention and 12 to usual care. Overall, 240 patients will be enrolled during an acute coronary syndrome hospitalization.
详细描述
Elevated LDL cholesterol levels are associated with an increased risk of adverse events after an acute coronary syndrome. The higher the LDL cholesterol level at patients' admission for acute coronary syndrome, the greater the intensity of lipid-lowering treatment to be adopted to obtain the greatest benefits in terms of reduction of all-cause and cardiovascular mortality.
Despite European Society of Cardiology guideline recommendations to achieve low LDL cholesterol targets in patients with acute coronary syndrome (halving of baseline LDL cholesterol values and reaching LDL cholesterol values < 55 mg/dl or < 40 mg/dl in the case of a second event within two years of the first), this is unlikely to happen in clinical practice. Recent observational studies, such as the Da Vinci and Santorini, provide important insights into the practical management of lipid-lowering therapy in post-ACS patients in daily clinical practice, showing that only about 20% of high- or very-high-risk patients achieve guideline-recommended targets.
On the other hand, aggressive control of modifiable risk factors could prevent up to 80% of premature deaths related to cardiovascular disease. This underscores the importance of healthcare professionals in maximizing prevention efforts. Improvements in community health could prevent millions of serious cardiovascular events each year if properly implemented.
New therapies, such as PCSK9 inhibitors (monoclonal antibodies) or siRNA (inclisiran), offer an option for further and faster LDL cholesterol reduction during the peri- and post-acute coronary syndrome period, associated with a marked improvement in prognosis.
However, the use of these pharmacological strategies is currently quite limited in clinical practice. Several conditions account for the reduced "adherence" of clinicians and patients to the recommended therapies. Health disparities due to socioeconomic status, age, race, gender and cost, limited access to healthcare, perceived side effects associated with lipid-lowering therapies, health literacy and the presence of comorbidities, are all factors contributing to the suboptimal use of proposed therapies. Furthermore, clinical factors, including failure to identify patients requiring LDL cholesterol reassessment, insufficient monitoring, and clinical inertia have been associated with an insufficient use of lipid-lowering therapies.
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
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and <80 years old.
- •Males and females at birth.
- •Baseline LDL-Cholesterol:
- •≥ 130 mg/dl (in statin-naïve patients or who have not followed a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment) or
- •≥110 mg/dl (in patients who have received stable moderate-intensity or low-intensity statin treatment in the 4 weeks prior to enrollment) or
- •≥100 mg/dl (in patients who have received stable treatment with high-intensity statins in the 4 weeks prior to enrollment)
- •Discharged at home
- •Ability to understand the requirements of the study and to provide informed consent
排除标准
- •Patients who have previously received or currently treated with PCSK9i (evolocumab or alirocumab) or siRNA (inclisiran)
- •Unstable clinical status (hemodynamic or electrical instability)
- •Uncontrolled cardiac arrhythmias, defined as recurrent, symptomatic ventricular tachycardia or atrial fibrillation or flutter with rapid ventricular response
- •Severe renal dysfunction, defined by eGFR < 30 mL/min/1.73 m2
- •Active liver disease or liver dysfunction, reported in the medical record or defined by AST or ALT levels > 3 times the upper limit of normal.
- •Reported intolerance to statins defined by the following criteria: inability to tolerate at least two different statins; intolerance associated with confirmed and intolerable statin-related adverse effects or significant biomarker abnormalities; improvement/resolution of symptoms or biomarkers following dose decrease or discontinuation; symptoms or changes in biomarkers not attributable to established predispositions.
- •Treatment with systemic steroids or systemic cyclosporine within the past 3 months (e.g., intravenously, intramuscularly, or orally)
- •Known active infection or severe hematologic, metabolic, or endocrine dysfunction as judged by the Investigator.
- •Current inclusion in other pharmacological and non-pharmacological experimental studies.
- •Pregnancy. For women of childbearing potential (age < 50 years and last menses <12 months prior to screening) who have not undergone tubal ligation, oophorectomy, or hysterectomy, pregnancy will be excluded from a pregnancy test prior to inclusion in the study.
- •Active neoplasia or very severe disease compromising short-medium term life expectancy.
- •Only for sites randomized to the interventional group:
- •Patients without a device suitable for App use (eg. Smartphone or tablet) or patients that do not consent to receive push notifications by the App.
研究组 & 干预措施
Quality-improvement educational intervention
Patients included in the interventional arm will be guided to download a smartphone App which will allow them:
- To see a 3-minute animated video aimed at explaining in layman terminology the benefits of intensifying LDL cholesterol reduction therapy, gaps in prescribing, reasons for clinical inertia, and motivations for patients to achieve recommended targets.
- To see a check-list intended to propose a conscious way of managing dyslipidemia by the patient in relation to the targets to be achieved.
- To include the ongoing lipid lowering therapy and enter the control LDL cholesterol value evaluated during hospitalization and that patient will perform in the days preceding the all the follow-up visits showing if goal has been achieved.
干预措施: Patient-oriented educational intervention (Other)
Usual care
Patients followed in the centers randomized to the control arm will be managed by usual care in accordance with local clinical guidance.
结局指标
主要结局
Number of patients achieving Guideline recommended LDL-Cholesterol goal
时间窗: 12 month
To compare the rate of patients with acute coronary syndrome who achieve the 2019 European Society of Cardiology/European Atherosclerosis Society guideline recommended LDL-Cholesterol goal (\<55 mg/dl or \<40 mg/dl in patients with recurrent events in the previous 24 months despite maximal lipid lowering treatment) at 12 months in sites following the interventional education protocol versus those receiving usual care.
次要结局
- Use of Injective Lipid Lowering Therapy(1 month)
- Number of participants with lipid lowering treatments related adverse events(6 months)
- Use of Injective Lipid Lowering Therapy(6 month)
- LDL-Cholesterol variation(12 months)
- Number of participants with lipid lowering treatments related adverse events(12 months)