EARLY: Educational Intervention to Improve Patient Awareness on Early LDL-C Lowering in Secondary Prevention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorHeart Care Foundation
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 and <80 years old.
Males and females at birth.
≥ 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Patient-oriented educational intervention
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Heart Care Foundation
Lead sponsor
Novartis Farma S.p.A.
Collaborator
Source ClinicalTrials.gov