Acute Coronary Syndromes, Chronic Coronary Syndromes
Conditions
Keywords
educational intervention, Patient awareness, LDL cholesterol, Lipid lowering drugs, Acute Coronary Syndrome
Brief summary
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.
Detailed description
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. Recently, the Italian Association of Hospital Cardiologists published a position paper on the treatment of hypercholesterolemia in patients with acute coronary syndrome. In the document, aimed at achieving the lipid targets outlined in the ESC/EAS 2019 guidelines more quickly than those currently recommended (from 8 weeks of the guidelines to 4 weeks of the Italian Association of Hospital Cardiologists document with a progressive and sustainable approach) and including new therapeutic options to reduce LDL cholesterol levels, a personalized therapeutic intervention based on LDL cholesterol levels at the time of hospital admission was proposed. As a consequence, implementing lipid-lowering treatments early according to patients' clinical risk and the pharmacological options available to clinicians, while improving patients' awareness of cardiovascular risk, remains one of the primary objectives of the clinical cardiologist in secondary prevention. Technology can effectively serve as an essential aid in achieving therapeutic targets. The introduction of dedicated applications could facilitate doctor-patient communication. On the basis of this evidence, the investigators designed the present study with the aim to evaluate if an educational intervention to improve the awareness on the relevance of obtaining LDL cholesterol recommended goals in patients with confirmed diagnosis of acute coronary syndrome, as compared to usual care can increase the proportion of patients at LDL cholesterol goal as suggested by 2019 ESC/EAS guidelines.
Interventions
OTHERPatient-oriented educational intervention
APP support
Sponsors
Novartis Farma S.p.A.
Heart Care Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Cluster randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 and \<80 years old. 2. Males and females at birth. 3. 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) 4. Discharged at home 5. Ability to understand the requirements of the study and to provide informed consent
Exclusion criteria
1. Patients who have previously received or currently treated with PCSK9i (evolocumab or alirocumab) or siRNA (inclisiran) 2. Unstable clinical status (hemodynamic or electrical instability) 3. Uncontrolled cardiac arrhythmias, defined as recurrent, symptomatic ventricular tachycardia or atrial fibrillation or flutter with rapid ventricular response 4. Severe renal dysfunction, defined by eGFR \< 30 mL/min/1.73 m2 5. 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. 6. 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. 7. Treatment with systemic steroids or systemic cyclosporine within the past 3 months (e.g., intravenously, intramuscularly, or orally) 8. Known active infection or severe hematologic, metabolic, or endocrine dysfunction as judged by the Investigator. 9. Current inclusion in other pharmacological and non-pharmacological experimental studies. 10. 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. 11. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients achieving Guideline recommended LDL-Cholesterol goal | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL-Cholesterol variation | 12 months | Change in LDL-Cholesterol from baseline. |
| Use of Injective Lipid Lowering Therapy | 1 month | Rate of patients who received PCSK9i inhibitors (monoclonal antibodies) or inclisiran during hospitalization (very fast track) |
| Number of participants with lipid lowering treatments related adverse events | 6 months | In the eCRF at the 6-month follow-up visit discontinuation of lipid-lowering treatments will be recorded together with side effects most frequently associated with these treatments (e.g., arthralgia, limb pain, flu-like symptoms/malaise, myalgia, back pain, and elevated transaminases). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular death (explorative objective) | 12 month | Assess the rate of cardiovascular deaths |
| New hospitalizations for atherothrombotic events (explorative objective) | 12 month | Assess the rate of new hospitalizations for atherothrombotic events. |
| All-cause mortality (explorative objective) | 12 month | Assess the rate of all-cause mortality |
| All-cause hospitalizations (explorative objective) | 12 month | Assess the rate of all-cause hospitalizations |
Countries
Italy
Contacts
Primary ContactLeonardo De Luca, MD
Outcome results
None listed