Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637657
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
Guided Optimisation of Long-term Disease rEduction in secoNdary Prevention of CVD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Guided Optimisation of Long-term Disease rEduction in secoNdary Prevention of CVD GOLDEN A Prospective Observational Study of Long-term Outcomes
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GOLDEN
Brief Summary:
The goal of this observational study is to evaluate the implementation of a first-time-right pharmacological treatment strategy in patients hospitalized with coronary artery disease
The main question it aims to answer is
Does early immediately post-event initiation of a full set of guideline-based individualized preventive medication lead to reductions in cardiovascular events compared to current practice incremental titration strategies
Researchers will compare the first-time-right strategy group to the current practice group to see if there are improvements in major adverse cardiac and cerebrovascular events MACE at 36 months
Participants will
Receive either the first-time-right strategy or current practice for secondary prevention
Be monitored data collection through routine clinical visits at baseline 8 weeks 12 and additional telephone contacts at 24 and 36 months after discharge
Complete online questionnaires at hospitalization 8 weeks 12 24 and 36 months after discharge
The main question it aims to answer is
Does early immediately post-event initiation of a full set of guideline-based individualized preventive medication lead to reductions in cardiovascular events compared to current practice incremental titration strategies
Researchers will compare the first-time-right strategy group to the current practice group to see if there are improvements in major adverse cardiac and cerebrovascular events MACE at 36 months
Participants will
Receive either the first-time-right strategy or current practice for secondary prevention
Be monitored data collection through routine clinical visits at baseline 8 weeks 12 and additional telephone contacts at 24 and 36 months after discharge
Complete online questionnaires at hospitalization 8 weeks 12 24 and 36 months after discharge
Detailed Description:
Rationale
Individuals with clinically established coronary artery disease are at high risk of recurrent events and death To reduce this risk incremental titration of preventive medication to reach pre-defined risk factor targets is recommended by international guidelines
However using this approach disappointing reductions in risk are generally attained mainly resulting from inadequate use of preventive medication The European 2021 Prevention guidelines recommend compressing preventive strategies into a maximum of two steps first attainment of minimal risk-factor targets followed by rapid individualized residual risk management 1 While the conventional interpretation of preventive guidelines has led to medication titration over months or even years - with suboptimal results the new guideline-based approach de facto constitutes a front-loaded first- time-right strategy where as early as during hospitalization a complete medication plan is formulated and implemented However the practical implementation and effects on clinical outcomes of such a strategy have not been investigated The investigators therefore aim to investigate the effects of implementing a first-time-right guideline-based pharmacological treatment strategy compared to current incremental individual-titration strategies in patients hospitalized with coronary artery disease As both treatment strategies constitute a different application of current international guidelines no experimental treatments are included The investigators will therefore conduct an observational study to investigate the effects of both strategies The investigators hypothesize that application of the first-time-right pharmacological strategy ie early immediately post-event initiation of a full set of guideline-based individualized preventive medications will lead to greater risk factor control and to reductions in cardiovascular events compared to current practice ie incremental titration strategies
Goals
Primary Objective To evaluate the impact of a first-time-right pharmacological risk factor management strategy according to the European 2021 Prevention guidelines compared with current practice ie incremental titration on major adverse cardiac- and cerebrovascular events MACE 4-point CVD death myocardial infarction ischemic or hemorrhagic stroke and ischemia-driven revascularization at 36 months Secondary objectives CVD death myocardial infarction stroke and ischemia-driven revascularization plus in 2 and 3-point MACE combinations acute limb ischemia carotid revascularization unplanned cardiovascular hospital readmission improvement in cardiovascular risk factors drug- targeted and lifestyle-related risk factors self-reported medication use and adherence scores quality of life
Study design
GOLDEN is a prospective observational study designed to evaluate the implementation of the guideline-based first-time-right strategy in at least 30 cardiology departments in the Netherlands Figure 1 Appendix Study supervision including data management and statistical analyses of the study will be performed and coordinated at the Amsterdam UMC assisted by the Dutch Network forCardiovascular Research WCN Utrecht The Netherlands
The study will be embedded in the collaboration of the partners of the Dutch Cardiovascular Alliance supporting the goal of reducing the cardiovascular disease burden in The Netherlands by collaboration in research and implementation Amsterdam UMC has the role of sponsor and is responsible for the scientific and operational leadership When all relevant national partners support the implementation goal of First Time Right participating centers will be recruited within the academic centers through NetherLands Heart Institute NLHI and non-academic centers through the Dutch Network for Cardiovascular Research WCN Utrecht The Netherlands Patient data will be captured and stored in an electronic database Castor and will only be available for the investigator sponsor WCN Werkgroep Cardiologische centra Nederland is a research network of cardiovascular investigators wwwWCNlife The network consists of nearly 60 cardiovascular research departments across the Netherlands The WCN office provides central support to both the sponsor and the participating sites through central feasibility site ID contracting recruitment and quality support The research professionals are employed by each individual site Data on patient inclusion and data quality will be shared with WCN for quality assurance purposes No individual patient data will be shared with WCN
Our observational study comprises two groups1 The current practice group constituting current secondary prevention practices treated patients ie incremental individual titration at treating physicians discretion 2 The first-time-right group when the first- time-right guideline-based strategy is implemented The study program is outlined in Figure 2 Appendix All centers will start including in the current practice arm After inclusion of 50 of the sample size a blanking period of 8 weeks will be observed where no inclusions will take place in any center This time period will be used to train all participating centers in the first-time-right strategy
Subsequently all centers will proceed to include in the first-time- right cohort The current practice treated patients group will provide data on current practices in the preventive treatment after hospitalization for acute coronary syndrome or coronary revascularization
Individuals with clinically established coronary artery disease are at high risk of recurrent events and death To reduce this risk incremental titration of preventive medication to reach pre-defined risk factor targets is recommended by international guidelines
However using this approach disappointing reductions in risk are generally attained mainly resulting from inadequate use of preventive medication The European 2021 Prevention guidelines recommend compressing preventive strategies into a maximum of two steps first attainment of minimal risk-factor targets followed by rapid individualized residual risk management 1 While the conventional interpretation of preventive guidelines has led to medication titration over months or even years - with suboptimal results the new guideline-based approach de facto constitutes a front-loaded first- time-right strategy where as early as during hospitalization a complete medication plan is formulated and implemented However the practical implementation and effects on clinical outcomes of such a strategy have not been investigated The investigators therefore aim to investigate the effects of implementing a first-time-right guideline-based pharmacological treatment strategy compared to current incremental individual-titration strategies in patients hospitalized with coronary artery disease As both treatment strategies constitute a different application of current international guidelines no experimental treatments are included The investigators will therefore conduct an observational study to investigate the effects of both strategies The investigators hypothesize that application of the first-time-right pharmacological strategy ie early immediately post-event initiation of a full set of guideline-based individualized preventive medications will lead to greater risk factor control and to reductions in cardiovascular events compared to current practice ie incremental titration strategies
Goals
Primary Objective To evaluate the impact of a first-time-right pharmacological risk factor management strategy according to the European 2021 Prevention guidelines compared with current practice ie incremental titration on major adverse cardiac- and cerebrovascular events MACE 4-point CVD death myocardial infarction ischemic or hemorrhagic stroke and ischemia-driven revascularization at 36 months Secondary objectives CVD death myocardial infarction stroke and ischemia-driven revascularization plus in 2 and 3-point MACE combinations acute limb ischemia carotid revascularization unplanned cardiovascular hospital readmission improvement in cardiovascular risk factors drug- targeted and lifestyle-related risk factors self-reported medication use and adherence scores quality of life
Study design
GOLDEN is a prospective observational study designed to evaluate the implementation of the guideline-based first-time-right strategy in at least 30 cardiology departments in the Netherlands Figure 1 Appendix Study supervision including data management and statistical analyses of the study will be performed and coordinated at the Amsterdam UMC assisted by the Dutch Network forCardiovascular Research WCN Utrecht The Netherlands
The study will be embedded in the collaboration of the partners of the Dutch Cardiovascular Alliance supporting the goal of reducing the cardiovascular disease burden in The Netherlands by collaboration in research and implementation Amsterdam UMC has the role of sponsor and is responsible for the scientific and operational leadership When all relevant national partners support the implementation goal of First Time Right participating centers will be recruited within the academic centers through NetherLands Heart Institute NLHI and non-academic centers through the Dutch Network for Cardiovascular Research WCN Utrecht The Netherlands Patient data will be captured and stored in an electronic database Castor and will only be available for the investigator sponsor WCN Werkgroep Cardiologische centra Nederland is a research network of cardiovascular investigators wwwWCNlife The network consists of nearly 60 cardiovascular research departments across the Netherlands The WCN office provides central support to both the sponsor and the participating sites through central feasibility site ID contracting recruitment and quality support The research professionals are employed by each individual site Data on patient inclusion and data quality will be shared with WCN for quality assurance purposes No individual patient data will be shared with WCN
Our observational study comprises two groups1 The current practice group constituting current secondary prevention practices treated patients ie incremental individual titration at treating physicians discretion 2 The first-time-right group when the first- time-right guideline-based strategy is implemented The study program is outlined in Figure 2 Appendix All centers will start including in the current practice arm After inclusion of 50 of the sample size a blanking period of 8 weeks will be observed where no inclusions will take place in any center This time period will be used to train all participating centers in the first-time-right strategy
Subsequently all centers will proceed to include in the first-time- right cohort The current practice treated patients group will provide data on current practices in the preventive treatment after hospitalization for acute coronary syndrome or coronary revascularization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None