Guided Optimisation of Long-term Disease rEduction in secoNdary Prevention of CVD

NCT06637657 | Recruiting DMC

• 1 other identifier: 2023.0331
• Study Type: observational
• Target: 5,586
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

Cardiovascular prevention; Coronary revascularisation; Pharmacological approach; Teachable moment; Major cardiovascular events; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 4-point MACE

  Composite of cardiovascular death, myocardial infarction, any documented stroke (ischemic or hemorrhagic), ischemia-driven revascularization.

  36 months

Secondary Outcomes (14)

• Uncombined MACE evaluations

  8 weeks, 12 months, 24 months, 36 months after discharge

• Combined outcomes: 2-point and 3-point MACE

  8 weeks, 12 months, 24 months, 36 months after discharge

• Extended MACE

  8 weeks, 12 months, 24 months, 36 months after discharge

• Unplanned cardiovascular hospital readmission

  8 weeks, 12 months, 24 months, 36 months after discharge

• LDL-cholesterol

  baseline= (max. 3 months) prior to event or revascularisation procedure, 8 weeks, 12 months after discharge

Other Outcomes (2)

• The iMTA Medical Consumption Questionnaire (iMCQ)

  baseline= between event or coronary intervention and discharge, 8 weeks, 12 months, 36 months

• The iMTA Productivity Cost Questionnaire

  baseline= between event or coronary intervention and discharge, 8 weeks, 12 months, 36 months

Study Arms (2)

'Current practice' group

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. (i.e. incremental, individual titration at treating physician's discretion)

Other: No intervention (observational study)

'First-time-right' (FTR) group

In line with the 2021 ESC Prevention guidelines, the FTR group will be treated according to the 'first-time-right' strategy(1). While no specific therapeutic protocols are mandated by our observational study, participating centers will be required to apply the 'first-time- right' strategy: i.e. the direct, in-hospital initiation or planned initiation of all guideline-recommended preventive pharmacotherapeutic treatments.

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

No intervention, only guideline implementation (observational study)

'Current practice' group; 'First-time-right' (FTR) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of all patients who have consented to the use of their clinical data and who are hospitalized at cardiology departments of participating hospitals (Dutch Network for Cardiovascular Research (WCN and University Medical Centers) in the Netherlands.

You may qualify if:

• \>18 years of age (no upper limit)
• Coronary event, i.e. ACS or coronary revascularisation
• Able to provide informed consent

You may not qualify if:

• (short-term planned) pregnancy or breast feeding
• Dialysis

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Dutch Network for Cardiovascular Research (WCN), Utrecht: collaborator
• Novartis Pharmaceuticals: collaborator
• Amarin Pharma Inc.: collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Related Publications (1)

• Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Angelantonio ED, Franco OH, Halvorsen S, Richard Hobbs FD, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice: Developed by the Task Force for cardiovascular disease prevention in clinical practice with representatives of the European Society of Cardiology and 12 medical societies With the special contribution of the European Association of Preventive Cardiology (EAPC). Rev Esp Cardiol (Engl Ed). 2022 May;75(5):429. doi: 10.1016/j.rec.2022.04.003. No abstract available. English, Spanish.

  PMID: 35525570 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Observation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Marjolein Snaterse, dr.

  Amsterdam UMC

  STUDY CHAIR

• Fabrice M.A.C. Martens, Prof. dr.

  Amsterdam UMC

  STUDY CHAIR

• Harald T. Jorstad, dr.

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon van den Bogaart, drs.

CONTACT

003120 5660703; m.vandenbogaart@amsterdamumc.nl

Marjolein Snaterse, dr.

CONTACT

m.snaterse@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: October 15, 2024
• Study Start: July 9, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

NL (1)