Clinical Trial

Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD

Recruiting
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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
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2020-06-11; most recent amendment 2023-06-09.
Status change: Not Yet Recruiting → Recruiting 2023-06-09
Trial Details
NCT Number NCT04433052
Lead Sponsor Tampere University
Conditions Coronary Heart Disease
Enrollment 12,000 participants
Start Date 2023-02-01
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2023-06-12