Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD
A Prospective Clinical Trial to Evaluate the Clinical Value and Cost-effectiveness of a Personalized Prevention Program in Patients With High Risk Stable Coronary Heart Disease
1 other identifier
interventional
12,000
6 countries
26
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
June 12, 2023
June 1, 2023
3.8 years
June 4, 2020
June 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 years follow-up
Secondary Outcomes (7)
To evaluate the difference between PPP arm to the UC arm in
3 years follow-up
To evaluate the difference between PPP arm to the UC arm in
3 years follow-up
To evaluate the difference between PPP arm to the UC arm in
3 years follow-up
To evaluate the difference between PPP arm to the UC arm in
3 years follow-up
To evaluate the difference between PPP arm to the UC arm in
3 years follow-up
- +2 more secondary outcomes
Study Arms (2)
Personalised prevention program (PPP)
EXPERIMENTALParticipants will be invited to return to the study site six times over a three year period to receive lifestyle coaching and exercise prescriptions. Eupropean Society of Cardiology/European Association of Preventive Cardiology (ESC/EAPC) -designed lifestyle counselling will be partially delivered by novel smartphone applications. Participants will also receive pharmaceutical treatment according to the ESC guideline for chronic coronary syndromes.
Usual care (UC)
NO INTERVENTIONParticipants will be referred back to usual care provided by their treating physicians. It is anticipated that physicians will treat these participants according to local usual medical practices. Patients randomized to UC group will not receive any treatment recommendations nor restrictions by the study investigators or nurses. Randomized UC patients are invited to site visits twice over a three year period.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Informed consent form signed by the study subjects.
- Male or female aged 30 to 80 years on the day of enrolment.
- \> 50% stenosis in one or more major coronary arteries on angiography or computerised tomography (CT) performed within the preceding one year (from enrolment visit).
- or Myocardial infarction (type I, II) during the preceding year.
You may not qualify if:
- Hospitalisation for acute coronary syndrome, myocardial infarction, stroke, coronary revascularisation or acute heart failure within the preceding one month (30 days). These subjects can be enrolled after a one-month stabilisation period, which begins from the time of the event.
- Subjects with NYHA class III-IV heart failure i.e. marked limitation in activity due to symptoms, comfortable only at rest.
- Uncontrolled arrhythmias such as ventricular tachycardias.
- Subjects undergoing dialysis due to severe renal disease.
- Diseases that severely disable exercising (per investigator's judgement), such as rheumatoid arthritis, neurological or orthopaedic diseases.
- Known aplastic or haemolytic anaemia.
- Concomitant non-coronary disease, such as malignancy that limits life expectancy to less than three years.
- Concurrent participation in another interventional study.
- Subjects not able and/or willing to attend all scheduled visits and comply with all study procedures and use a smartphone application.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Helsinki University Hospital
Helsinki, Finland
Mehiläinen
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Klinik am See
Berlin, Germany
CCV-MVZ
Frankfurt, Germany
Heidelberg University
Mannheim, Germany
Technise Universität Munchen
München, Germany
Herzklinik Ulm
Ulm, Germany
Hellenic Red Cross Hospital
Athens, Greece
Konstantopoulio Hospital
Athens, Greece
Sismanoglion Hospital
Athens, Greece
The Biomedical Research Foundation of the Academy Athens
Athens, Greece
University Hospital Genova
Genova, Italy
Multi Medica, Care and Research Institute
Milan, Italy
Casilino Hospital Rome
Rome, Italy
University Hospital Turin
Turin, Italy
University of Bialystok
Bialystok, Poland
Medical University of Silesia
Katowice, Poland
Jagellonian University Medical College
Krakow, Poland
University of Lublin
Lublin, Poland
Nicolaus Copernicus University
Toruniak, Poland
National Institute of Cardiology
Warsaw, Poland
Hospital de Santa Cruz-CHLO
Carnaxide, Portugal
Hospital do Espirito Santo
Lisbon, Portugal
Hospital Santa Maria-CHULN/FMUL
Lisbon, Portugal
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Reijo Laaksonen, MD, PhD
Tampere University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Project Director
Study Record Dates
First Submitted
June 4, 2020
First Posted
June 16, 2020
Study Start
February 1, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
June 12, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- opens 2 years after last study patient visit, open for 18 years until IPD deletion
- Access Criteria
- Steering Committee decision, application needed
EU open access policy