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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04433052
Other study ID # CPP-2020-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date December 2026

Study information

Verified date June 2023
Source Tampere University
Contact Hanna Marttila, MSc
Phone +358407240771
Email hanna.marttila@tuni.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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Study Design


Intervention

Behavioral:
personalised prevention program (PPP)
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.

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Sponsors (1)

Lead Sponsor Collaborator
Tampere University

Countries where clinical trial is conducted

Finland,  Germany,  Greece,  Italy,  Poland,  Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 3 years follow-up
Secondary 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) 3 years follow-up
Secondary 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 3 years follow-up
Secondary To evaluate the difference between PPP arm to the UC arm in All-cause mortality 3 years follow-up
Secondary 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 3 years follow-up
Secondary 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. 3 years follow-up
Secondary • 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
3 years follow-up
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