Inclisiran
DrugImplementation of a follow-up program that incorporates Inclisiran treatment in patients with a history of chronic coronary syndrome
NCT Number: NCT06421363
1.1. Background Cardiovascular disease (CVD) remains the leading cause of death in our country for over four decades. The pathophysiology of CVD begins with various cardiovascular risk factors (CRFs) and their poor management, leading to subclinical lesions in target organs such as albuminuria or left ventricular hypertrophy, which may evolve into CVD. This progression is referred to as the cardiovascular continuum. Patients with chronic cardiovascular conditions require comprehensive periodic health monitoring in primary care (PC), including lifestyle advice and an assessment of comorbidities. Risk factors linked to disease progression are monitored and managed, along with medication reconciliation and planning follow-up care. Such activities, especially post-COVID, help maintain clinical stability and organize healthcare demand, reducing unnecessary interventions and costs. In Galicia, continuity of care programs for ischemic heart disease focus on optimizing service delivery at appropriate levels, including electronic consultations that improve healthcare accessibility, outcomes, and cost-effectiveness. Introducing Inclisiran for chronic CVD patients post-acute coronary syndrome (ACS) hospitalization might streamline care continuity, reducing healthcare costs and improving outcomes.
1.2. Purpose The disruption of care continuity in patients post-ACS increases their risk of mortality and hospitalizations due to coronary complications and comorbidities, as well as emergency visits and unplanned healthcare interactions, thus elevating healthcare costs. We propose reorganizing care continuity for ACS patients by establishing a PC pathway with scheduled semi-annual visits to assess overall and cardiovascular health and to evaluate patient prognosis and healthcare resource utilization.
2. Objectives 2.1. Primary Objectives The main goal is to evaluate whether a follow-up program incorporating Inclisiran treatment in patients with chronic coronary syndrome can optimize follow-up (reducing unscheduled visits to PC and hospital emergency departments), improve control of risk factors (like physical activity, adherence to a Mediterranean diet, lipid profiles, blood pressure, glycemic profile, and renal function), and decrease direct economic costs.
2.2. Secondary Objectives The secondary objectives include analyzing adherence to prescribed chronic pharmacological treatment, factors driving higher demand among patients with chronic coronary syndrome, reasons for emergency visits, hospital admissions, and causes of mortality among these patients.
3. Methodology 3.1. Study Design A pilot, multicentric, analytical intervention study will be conducted involving five health centers in the Santiago de Compostela health area, with specific inclusion and exclusion criteria outlined. The study will monitor patients over 27 months, following a detailed protocol.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Cenro de Salud de La Estrada, A Estrada, A Coruña, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
At least one of the following:
Exclusion criteria
Implementation of a follow-up program that incorporates Inclisiran treatment in patients with a history of chronic coronary syndrome
Time frame: 2 YEARS
Number of unplanned visits for patients with chronic coronary syndrome in family medicine, nursing, telemedicine, and hospital consultations during follow-up.
Time frame: 2 YEARS
Change in adherence to the Mediterranean diet using the validated questionnaire PREDIMED. The test consists of 14 questions, in which the higher the score, the better the relationship with a healthy life.
TOTAL SCORE: < 9 low adherence >= 9 good adherence to the Mediterranean diet
Time frame: 2 YEARS
Change in LDL cholesterol levels in mg/dL from baseline to follow-up. Unit of Measure: mg/dL
Time frame: 2 YEARS
Change in systolic/diastolic blood pressure (specify how it's measured, e.g., mmHg).
Unit of Measure: mmHg.
Time frame: 2 YEARS
Adherence to medication, measured as the proportion of days covered (PDC) based on the total number of days medications were supplied through the electronic prescription system.
Unit of Measure: Percentage (%) Calculation of the PDC for a specific drug: The numerator represents the total number of days a drug was supplied between the first and last electronic prescription picked up (a + b + c + d). The denominator represents the total number of days in the interval (from x to t). PDC: proportion of days covered.
Time frame: 2 YEARS
Outcome Measure: Number of hospital emergency attendances during the study period.
Unit of Measure: Number of attendances.
Time frame: 2 YEARS
Hospital Admissions Description: Number of hospital admissions related to cardiovascular disease Unit of Measure: Number of admissions Mortality Description: Number of deaths and primary cause during the study period. Unit of Measure: Number of admissions
Time frame: 2 YEARS
Physical Activity Description: Change in physical activity, assessed via a validated questionnaire SF-36 Unit of Measure: Score on the questionnaire.
Scale Details:
Full Scale Name: Short Form (36) Health Survey Scale Range: The SF-36 scale typically ranges from 0 to 100. Interpretation: Higher scores indicate a better quality of life and health status.
Time frame: 2 YEARS
Costs associated with unplanned medical visits, adherence, hospitalizations, and medication adherence.
Unit of Measure: Cost (currency)
Time frame: 2 years
Outcome Measure: Number of unplanned nursing consultations in primary care.
Unit of Measure: Number of consultations.
Time frame: 2 yeras
Outcome Measure: Number of unplanned family doctor consultations in primary care.
Unit of Measure: Number of consultations.
Time frame: 2 years
Outcome Measure: Number of attendances at continuous care points in primary care.
Unit of Measure: Number of attendances.
Time frame: 2 yeras
Outcome Measure: Number of telemedicine hospital consultations.
Unit of Measure: Number of consultations.
Time frame: 2 years
Outcome Measure: Number of in-person hospital consultations.
Unit of Measure: Number of consultations.
Time frame: 2 years
Outcome Measure: Number of hospital emergency attendances.
Unit of Measure: Number of attendances.
Time frame: 2 years
Outcome Measure: Lab samples results.
Unit of Measure: Specific measure (e.g., mg/dL for cholesterol).
Contact information is provided by the study sponsor or research team.
JOSE SEIJAS AMIGO, PhD MS Pharm
CONTACT
SERGIO CINZA SANJURJO, PHD MD
CONTACT
Jose Seijas Amigo
Other
Acronym: CAPRICI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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