Prospective clinical study with two parts: PART A: a prospective biomarker-based risk screening study in coronary heart disease (CHD) subjects PART B: a nested randomized clinical trial (RCT) in an enriched subpopulation of high-risk stable CHD subjects PART A: 12 000 subjects with stable CHD PART B: 2000 subjects with high risk of CV events will be randomized to usual care (UC) or personalised prevention program (PPP) i.e. 1000 subjects per arm. Study purpose is to assess the clinical value and cost-effectiveness of a personalised prevention program (PPP) in high-risk, stable coronary heart disease (CHD) subjects and to prospectively validate risk screening biomarkers
Primary Objectives: PART A: * To prospectively validate biomarkers in risk stratification among stable CHD subjects, i.e. evaluation of the biomarker performance in accurately predicting CV events including CV death, nonfatal MI, HF events * To identify high-risk CHD subjects for the subsequent RCT, i.e. 15-20% of the screened patient population at the highest risk PART B • To demonstrate whether a personalised prevention (PPP) strategy in high-risk CHD subjects results in a decreased risk of cardiovascular (CV) events (CV death, nonfatal myocardial infarction (MI) or heart failure (HF) events) as compared to the local usual care (UC) Secondary Objectives: * To evaluate the difference between the PPP arm to the UC arm as listed in section outcomes. * To evaluate the health economic value of the PPP * To prospectively study associations (in all enrolled subjects) between separate biomarkers (CERT2, hs-troponin, proBNP, Cystatin C) or their score (CoroPredict) In addition to the above-listed primary and secondary objectives of the study, the following analysis will be carried out based on the data to be collected during the trial: * Effect of personalised prevention on behavioural change. * Effect of behavioural change on CV outcomes and blood pressure. * Identification of key components and risk factors affecting effectiveness of the PPP. * Inter-relationship between nutrition and exercise will be evaluated. Nutrition parameters will be based on questionnaires and biomarkers (Trimethylamine N-oxide (TMAO), Trimethyllysine (TML), carnitines and their metabolites). * Effect of the use of the CoroPrevention Tool Suite (EXPERT tool) on the agreement between exercise prescriptions generated by cardiovascular nurses to subjects with CVD, and the ESC guideline-directed exercise prescriptions * Effect of greater adherence to EXPERT tool-driven exercise prescriptions by clinicians and subjects, on CVD risk, physical fitness, and prognosis (hospitalisations, adverse events, mortality) in subjects with CVD. * Effect of the use of the EXPERT tool-driven medication decision support system on the agreement between medication prescriptions generated by cardiovascular nurses to subjects with CVD, and the ESC guideline-directed medication prescriptions * Effect of better adherence by both clinicians and subjects to ESC guideline prescriptions, driven by the medication decision support system within the EXPERT tool, on CVD risk and prognosis (hospitalisations, adverse events, mortality) in subjects with CVD. * Investigation of the user experience and user acceptance of the CoroPrevention Tool Suite.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
12,000
Study subjects in the PPP arm will be invited to return to the study site six times over a three-year period (at V2/start of the study, V3/mo2, V4/mo6, V5/mo12, V6/mo18 and V7/mo36) to receive lifestyle coaching and exercise prescriptions led by a delegated member of the site staff and supervised by the investigator. Information on drug treatment will also be given by the investigator. These activities will be assisted by digital tools specifically designed for this study, the CoroPrevention Tool Suite.
Helsinki University Hospital
Helsinki, Finland
RECRUITINGMehiläinen
Helsinki, Finland
RECRUITINGKuopio University Hospital
Kuopio, Finland
NOT_YET_RECRUITINGOulu University Hospital
Oulu, Finland
RECRUITINGKlinik am See
Berlin, Germany
NOT_YET_RECRUITINGCCV-MVZ
Frankfurt, Germany
WITHDRAWNHeidelberg University
Mannheim, Germany
NOT_YET_RECRUITINGTechnise Universität Munchen
München, Germany
NOT_YET_RECRUITINGHerzklinik Ulm
Ulm, Germany
NOT_YET_RECRUITINGHellenic Red Cross Hospital
Athens, Greece
NOT_YET_RECRUITING...and 16 more locations
To demonstrate whether a PPP strategy in high-risk CHD subjects results in a decreased risk of CV events (CV death, nonfatal MI or HF events) compared to the UC
• The time from randomisation to the occurrence of the first CV event included in the composite endpoint of the study (CV death, nonfatal MI, HF events) over 3 years follow-up.
Time frame: 3 years follow-up
To evaluate the difference between PPP arm to the UC arm in
o The times from randomisation to the occurrence of the specific items included in the composite endpoint (CV death, nonfatal MI, HF event) over 3 years follow-up
Time frame: 3 years follow-up
To evaluate the difference between PPP arm to the UC arm in
o The times from randomisation to the occurrence of secondary CV events (unstable angina, stroke and coronary revascularisations excluding those elective revascularisations that have been planned prior to randomisation)
Time frame: 3 years follow-up
To evaluate the difference between PPP arm to the UC arm in
o Treatment adherence; measured by compliance laboratory assessments and in the PPP group, also with activity reports
Time frame: 3 years follow-up
To evaluate the difference between PPP arm to the UC arm in
All-cause mortality
Time frame: 3 years follow-up
To evaluate the difference between PPP arm to the UC arm in
Incidence of additional clinical endpoints: diabetes mellitus type 2 (DM2), chronic kidney disease (CKD), peripheral artery disease (PAD) and hypertension
Time frame: 3 years follow-up
To evaluate the health economic value of the PPP
o A cost-effectiveness analysis of PPP versus UC will be undertaken, based on evidence from the randomised clinical trial (RCT) portion of the study, using within-trial analysis and long-term cost-effectiveness modelling for the six countries participating in the CoroPrevention trial: Finland, Poland, Greece, Portugal, Italy, and Germany.
Time frame: 3 years follow-up
• To prospectively study associations (in all enrolled subjects) between separate risk biomarkers (CERT2, hs-troponin , proBNP, Cystatin C) or their score (CoroPredict) and
* Primary composite CV event (CV death, MI, HF events) * Specific CV events (CV death, nonfatal MI, HF events) separately * Specific secondary CV events (unstable angina, stroke, coronary revascularisations) * Incidence of DM2, CKD, PAD and hypertension
Time frame: 3 years follow-up
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