Health TrialsbyHealthPanel

EARLY: Educational Intervention to Improve Patient Awareness on Early LDL-C Lowering in Secondary Prevention

ConditionsAcute Coronary SyndromesChronic Coronary Syndromes
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Patient-oriented educational intervention

    Other intervention

    APP support

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Quality-improvement educational interventionExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of patients achieving Guideline recommended LDL-Cholesterol goal

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.

Time frame
12 month

Secondary outcomes

1

LDL-Cholesterol variation

Change in LDL-Cholesterol from baseline.

Time frame
12 months
2

Use of Injective Lipid Lowering Therapy

Rate of patients who received PCSK9i inhibitors (monoclonal antibodies) or inclisiran during hospitalization (very fast track)

Time frame
1 month
3

Use of Injective Lipid Lowering Therapy

Rate of patients who received PCSK9i inhibitors (monoclonal antibodies) or inclisiran during hospitalization (very fast track)

Time frame
6 month
4

Number of participants with lipid lowering treatments related adverse events

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).

Time frame
6 months

Other outcomes

1

Cardiovascular death (explorative objective)

Assess the rate of cardiovascular deaths

Time frame
12 month
2

New hospitalizations for atherothrombotic events (explorative objective)

Assess the rate of new hospitalizations for atherothrombotic events.

Time frame
12 month
3

All-cause mortality (explorative objective)

Assess the rate of all-cause mortality

Time frame
12 month
4

All-cause hospitalizations (explorative objective)

Assess the rate of all-cause hospitalizations

Time frame
12 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heart Care Foundation

Lead sponsor

Novartis Farma S.p.A.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: