Hyperlipidaemia/ high cholesterol post myocardial infarction
Conditions
Interventions
Patients are treated according to cholesterol treatment guidelines. The choice
of PCSK-9 inhibitor is directed by the protocol. When a PCSK-9 inhibitor needs
to be prescribted, alicobumab is the dru
Sponsors
WCN (Werkgroep Cardiologische centra Nederland)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Admission because of type I (N)STEMI, and - History of ASCVD (i.e., cerebrovascular disease (Transient ischemic attack, cerebral infarction, amaurosis fugax, retinal infarction), Coronary artery disease (unstable Angina pectoris, MI, ACS, coronary revascularization (coronary angioplasty or surgical procedure for coronary bypass)), Peripheral artery disease (Symptomatic and documented obstruction of an distal extremity artery or surgical operation (percutaneous transluminal angioplasty, bypass or amputation), and/or a history of T2DM.
Exclusion criteria
Exclusion criteria: - Age 70 years ánd a Clinical Frailty Score >3. o To measure the frailty score, the validated Dutch translation of the Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale will be used (table 2) - Pregnancy and lactating women - Known intolerance for alirocumab - Active PCSK9-i therapy - Participation in lipid modifying drug trials - Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study endpoint: - Proportion of patients with LDL-C >1.8 mMol/L during stepwise incremental lipid modifying therapy with respectively a statin, statin + ezetimibe. | — |
Secondary
| Measure | Time frame |
|---|---|
| Study parameters: - Medical history: ASCVD; T2DM; developing allergies or intolerances to alirocumab, ezetimibe or statins - LDL-C plasma levels at each consecutive step - Optional: non-HDL plasma levels at each consecutive step - Prescription preference for atorvastatin or rosuvastatin to achieve "high intensity statin therapy" (HIST) - % of patients that tolerates sustained HIST on atorvastatin or on rosuvastatin - % of patients that does NOT tolerate HIST with atorvastatin, but does tolerate HIST when switching to rosuvastatin - % of patients that does NOT tolerate HIST with rosuvastatin, but does tolerate HIST when switching to atorvastatin - % of patients that reaches target LDL 1.8 OR LDL 1.8 mMol/l, with or without alirocumab - Non-HDL-C levels in patients with LDL 2 mMol/l, with or without alirocumab - Prescription preference when atorvastatin 1dd40mg does not meet the LDL-target - Creatinine kinase in patients with statin intolerance - % of patients with an LDL =75 yr), diabetes, prior stroke, prior CABG, peripheral artery disease, eGFR | — |
Countries
Netherlands
Outcome results
None listed