Unmet LDL-C target in very high risk cardiovascular patients

Prevalence of unmet target LDL-C recommendations in very high risk patients despite high intensity lipid modifying therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21157

Enrollment

1000

Registered

2019-02-26

Start date

2019-01-11

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidaemia/high cholesterol post myocardial infarction

Interventions

Patiënten worden volgens de richtlijn cholesterolbehandeling behandeld, met stapsgewijze cholesterolbehandeling (HIST, HIST+ ezetimibe, HIST+ezetimibe + PCSK9-i). De keuze van de PCSK9 remmer is in PE

Other intervention

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Opname voor ACS: (N)STEMI type I - Voorgeschiedenis van minimaal 1: atherosclerose (ASCVD, cerebrovasculaire aandoeningen, cardiovasculaire aandoening of perifeer vaatlijden)/ diabetes type II/ bekende statine intolerantie

Exclusion criteria

Exclusion criteria: - Leeftijd <18 jaar - Leeftijd >70 jaar en kwetsbaarheidsscore >3 Kwetsbaarheidsscore middels de gevalideerde Nederlandse vertaling van de Canadese Studie van Gezondheid en Leeftijd (CSHA) Klinische Kwetsbaarheidsscore wordt gebruikt - Zwangerschap en vrouwen die borstvoeding geven - Bekend met alirocumab intolerantie - Actieve PCSK-remmer therapie - Deelname aan dyslipidaemie onderzoek - Levensverwachting <1 jaar

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 mMol/l while NOT on HIST - % of patients that compared to baseline achieves 50% LDL reduction ([1] patients not on HIST; [2] patients on HIST; [3] patients on HIST + ezetimibe; [4] patients on HIST + ezetimibe + alirocumab) - % of patients that compared to baseline achieves 50% LDL reduction AND LDL >1.8 OR LDL =1.8 (patient-groups 1-4) - non-HDL-C levels in patients with LDL =1.8 mMol/l and in patients with LDL >1.8 mMol/l, with or without alirocumab - Non-HDL-C levels in patients with LDL =1.8 mMol/l ánd triglycerides >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 =1.8 mMol/l after one year on HIST - % of patients with an LDL =1.8 mMol/l after one year on HIST + ezetimibe - % of patients with an LDL =1.8 mMol/l after one year on HIST + ezetimibe + alirocumab Components of the TIMI Risk Score for Secondary Prevention (TRS 2_P): - CHF, hypertension, age (=75 yr), diabetes, prior stroke, prior CABG, peripheral artery disease, eGFR <60, smoking	—

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 mMol/l while NOT on HIST - % of patients that compared to baseline achieves 50% LDL reduction ([1] patients not on HIST; [2] patients on HIST; [3] patients on HIST + ezetimibe; [4] patients on HIST + ezetimibe + alirocumab) - % of patients that compared to baseline achieves 50% LDL reduction AND LDL >1.8 OR LDL =1.8 (patient-groups 1-4) - non-HDL-C levels in patients with LDL =1.8 mMol/l and in patients with LDL >1.8 mMol/l, with or without alirocumab - Non-HDL-C levels in patients with LDL =1.8 mMol/l ánd triglycerides >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 =1.8 mMol/l after one year on HIST - % of patients with an LDL =1.8 mMol/l after one year on HIST + ezetimibe - % of patients with an LDL =1.8 mMol/l after one year on HIST + ezetimibe + alirocumab Components of the TIMI Risk Score for Secondary Prevention (TRS 2_P): - CHF, hypertension, age (=75 yr), diabetes, prior stroke, prior CABG, peripheral artery disease, eGFR <60, smoking 

—

Contacts

Public ContactAstrid Schut

Werkgroep Cardiologische centra Nederland

a.schut@wcn.life+3130 223 9937

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)