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Ischemic Heart DiseasePhase 4CAPRICINCT06421363

Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease

A Phase 4 study testing Inclisiran in people with Ischemic Heart Disease and Acute Coronary Syndrome, run by Jose Seijas Amigo at 6 sites in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Inclisiran
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
6 sitesSpain
Study dates
1 Jun 2024to 1 Aug 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years
  • Prior diagnosis of chronic coronary disease
  • At least one of the following:
  • Type 2 diabetes mellitus
  • Familial hypercholesterolemia
  • Recurrent coronary disease
Show all 13Show fewer
  • Chronic kidney disease
  • Currently undergoing pharmacological treatment with high-potency statins, with or without ezetimibe. The allowed statins and daily doses are:
  • Atorvastatin 80mg
  • Rosuvastatin 20mg
  • Rosuvastatin 40mg
  • Patients on other statins or lower doses are acceptable if there has been documented intolerance to the specified molecules and doses.
  • Blood analysis with a lipid profile in the last 6 months and with the current treatment showing LDL levels >100mg/dl.

Who cannot join

  • Not receiving statins in the therapeutic regimen.
  • Concomitant treatment with PCSK9 inhibitors.
  • Pregnancy, breastfeeding, or a desire to conceive by the patient.
  • Patients who, in the opinion of the investigator, are unable to adequately follow up in the chronic care program under routine clinical practice.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

SERGIO CINZA SANJURJO, PHD MD contact

+34915002171

scinzas@semergen.es

JOSE SEIJAS AMIGO, PhD MS Pharm contact

+34981955764

jose.seijas.amigo@sergas.es

6 sites in 1 country

Spain6 sites

  • Cenro de Salud de La Estrada

    A Estrada, A Coruña

    DANIEL REY ALDANA

    DANIEL REY ALDANA

  • Centro de Salud de Milladoiro

    Ames, A Coruña

    SERGIO CINZA, scinzas@semergen.es

    SERGIO CINZA SANJURJO

  • Centro de Salud de Melide

    Melide

    MONICA BARRAL CARREGAL

    MONICA BARRAL CARREGAL

  • Centro de Salud A Cañiza

    Pontevedra

    TERESA FERREIRO

    TERESA FERREIRO

  • Centro de Salud de Ribeira

    Ribeira, A Coruña

    ISABEL REGO

    ISABEL REGO

  • Hospital Clinico Univesitario de Santiago de Compostela

    Santiago de Compostela, A Coruña, 15706

    JOSE RAMON GONZALEZ JUNATEY, +34981950000, jose.ramon.gonzalez.juanatey@sergas.es

    JOSE SEIJAS AMIGO, +34981955764, jose.seijas.amigo@sergas.es

Other trials in Spain

About this study

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.

Read more
  1. 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.

  1. 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.
Being tested
Inclisiran
Keywords
inclisiran
Medical subject headings
Myocardial Ischemia, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InclisiranDrug

    Implementation of a follow-up program that incorporates Inclisiran treatment in patients with a history of chronic coronary syndrome

Study groups in NCT06421363
Study groupRoleWhat they receive
CONTROL GROUPNo interventionNot described
INTERVENTIONAL GROUPExperimentalNot described
Receives: Drug: Inclisiran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Unplanned Medical Visits

    Number of unplanned visits for patients with chronic coronary syndrome in family medicine, nursing, telemedicine, and hospital consultations during follow-up.

    Measured: 2 YEARS

  2. Variation in Adherence to the Mediterranean Diet

    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

    Measured: 2 YEARS

  3. Change in Lipid Profile.

    Change in LDL cholesterol levels in mg/dL from baseline to follow-up. Unit of Measure: mg/dL

    Measured: 2 YEARS

  4. Change in Blood Pressure

    Change in systolic/diastolic blood pressure (specify how it's measured, e.g., mmHg).

    Unit of Measure: mmHg.

    Measured: 2 YEARS

Secondary outcomes (12)

  1. Adherence to Medication

    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.

    Measured: 2 YEARS

  2. Emergency Room Attendances

    Outcome Measure: Number of hospital emergency attendances during the study period.

    Unit of Measure: Number of attendances.

    Measured: 2 YEARS

  3. Patient Prognosis

    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

    Measured: 2 YEARS

  4. Change in Patient Risk Factors

    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.

    Measured: 2 YEARS

  5. Cost Analysis

    Costs associated with unplanned medical visits, adherence, hospitalizations, and medication adherence.

    Unit of Measure: Cost (currency)

    Measured: 2 YEARS

  6. Healthcare Organization 1

    Outcome Measure: Number of unplanned nursing consultations in primary care.

    Unit of Measure: Number of consultations.

    Measured: 2 years

  7. Healthcare Organization 2

    Outcome Measure: Number of unplanned family doctor consultations in primary care.

    Unit of Measure: Number of consultations.

    Measured: 2 yeras

  8. Healthcare Organization 3

    Outcome Measure: Number of attendances at continuous care points in primary care.

    Unit of Measure: Number of attendances.

    Measured: 2 years

  9. Healthcare Organization 4

    Outcome Measure: Number of telemedicine hospital consultations.

    Unit of Measure: Number of consultations.

    Measured: 2 yeras

  10. Healthcare Organization 5

    Outcome Measure: Number of in-person hospital consultations.

    Unit of Measure: Number of consultations.

    Measured: 2 years

  11. Healthcare Organization 5

    Outcome Measure: Number of hospital emergency attendances.

    Unit of Measure: Number of attendances.

    Measured: 2 years

  12. Lab samples results

    Outcome Measure: Lab samples results.

    Unit of Measure: Specific measure (e.g., mg/dL for cholesterol).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06421363
Sponsor's protocol ID
CORONARIA 1/2023
Acronym
CAPRICI
Status last verified
May 2024
First submitted
24 Apr 2024
Last updated
20 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inclisiran in people with Ischemic Heart Disease and Acute Coronary Syndrome, run by Jose Seijas Amigo at 6 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact SERGIO CINZA SANJURJO, PHD MD (+34915002171, scinzas@semergen.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Unplanned Medical Visits (time frame: 2 YEARS). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06421363.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.

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