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Acute Coronary SyndromeFORCE-ACSNCT03823547

Future Optimal Research and Care Evaluation

An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by J.M. ten Berg at 4 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Rationale: Acute coronary syndrome (ACS) is the leading cause of death worldwide. To improve cardiovascular care, research is needed. Current guidelines are mainly based on well controlled RCT's, though evaluation of the impact of such RCT's in the real world is missing. Read more about this study

Who is it for?
Ages 18 years and older
How many people
99,999 participants
Where
4 sitesNetherlands
Study dates
1 Jan 2015to 30 Jun 2050
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients admitted to the hospital ward with acute coronary syndrome or symptoms suggestive for acute coronary syndrome are invited to participate in the registry.

Who may be able to join

  • All patients presenting with ACS
  • Age ≥ 18 years

Who cannot join

  • No oral or signed informed consent available.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dean R.P.P. Chan Pin Yin, MD contact

088 - 320 12 28

d.chanpinyin@antoniusziekenhuis.nl

Jur M. Ten Berg, MD, PhD contact

088 - 320 13 82

j.ten.berg@antoniusziekenhuis.nl

Netherlands4 sites, 4 recruiting

  • Gelre Ziekenhuizem

    Apeldoorn, Gelderland, 7334 DZ

    D. M. Nicastia, MD

    Recruiting

  • Rijnstate Arnhem

    Arnhem, Gelderland, 6815 AD

    R. M. Tjon, MD

    Recruiting

  • Gelderse Vallei

    Ede, Gelderland, 6716 RP

    R. Walhout, MD, PhD

    Recruiting

  • Ziekenhuis Rivierenland

    Tiel, Gelderland, 4002 WP

    J. Langerveld, MD, PhD

    Recruiting

Other trials in Netherlands

About this study

Official title: Future Optimal Research and Care Evaluation: On the Way to "Personalized Medicine" With an Ongoing Registry of Patients in Daily Clinical Practice (Hart Beter/ FORCE-ACS)

Rationale: Acute coronary syndrome (ACS) is the leading cause of death worldwide. To improve cardiovascular care, research is needed. Current guidelines are mainly based on well controlled RCT's, though evaluation of the impact of such RCT's in the real world is missing. In order to evaluate the impact and to overcome certain limitations of RCT's, a more practical approach is required. In this sense the use of nonrandomized observational studies is an important tool for determining the effectiveness of a therapy in routine clinical practice. One way to gain insight in characteristics of patients presenting in daily clinical practice, is to simply register these characteristics in a prospective manner with adequate follow up.

Objective: To create an ongoing registry for evaluation of clinical long-term impact of diagnostics, various treatments and devices used for ACS, for research and evaluation of quality of care and to evaluate and improve regional quality of care and cooperation between PCI and non-PCI centers.

Read the detailed description

Rationale:

Acute coronary syndrome (ACS) is the leading cause of death worldwide. To improve cardiovascular care, research is needed. Current guidelines are mainly based on well controlled RCT's, though evaluation of the impact of such RCT's in the real world is missing. Different clinical settings, non-ideal therapy adherence and broader patient populations in the real world than those studied in traditional RCTs may however provide different results. Furthermore, RCTs are intrinsically limited to answer questions about a specific population of interest, require substantial resource investments and may have limitations in investigating certain issues for ethical reasons.

In order to evaluate the impact and to overcome certain limitations of RCT's, a more practical approach is required. In this sense the use of nonrandomized observational studies is an important tool for determining the effectiveness of a therapy in routine clinical practice. One way to gain insight in characteristics of patients presenting in daily clinical practice, is to simply register these characteristics in a prospective manner with adequate follow up. These characteristics may include clinical parameters but also possibly genetic information. Such a detailed registry is now possible due to improvements in information technology, as electronic patient records permit more (semi-) automatic and uniform capture of clinical parameters and outcomes. While observational studies may often be limited in their ability to account for confounding and bias due to patient selection, recent evidence has shown that by careful use of advanced statistical analytical methods and open reporting paradigms the quality of the level of evidence is excellent.

Objectives:

  1. To create a database for future research, especially in the view of personalized medicine, and quality of care.
  2. To evaluate clinical long-term impact of medication, devices and diagnostic tools used for patients with an ACS.
  3. To test the efficacy and safety of any new drug/device versus the current treatment and the results of any drug/device in daily practice versus in trials
  4. To evaluate routine follow-up and current health-care pathways in patients with acute coronary syndrome in the Dutch healthcare system in terms of mortality, recurrent ischemic events, recurrent hospital admissions and quality of life
  5. To evaluate the use of risk scores (e.g. PRECISE-DAPT score, DAPT-score) to define the optimal duration of antiplatelet drugs
  6. To evaluate follow-up of patients referred to general practitioners as compared to of patients continued to be treated by cardiologists
  7. To increase adherence to current guidelines, taking into account the ongoing improvements of modern patient care and future changes of treatment guidelines in patients with ACS in order to improve secondary prevention in terms of reducing recurrent ischemic events and preventing adverse outcomes, such as bleeding
Keywords
DAPT, Dual Antiplatelet Therapy, Myocardial infarction, Acute Coronary Syndrome, Ticagrelor, Prasugrel, Clopidogrel, Thrombosis, Myocardial Ischemia, Platelet aggregation inhibitors, Risk scores, Cardiovascular diseases
Medical subject headings
Acute Coronary Syndrome, Myocardial Infarction, Thrombosis, Myocardial Ischemia, Cardiovascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with

    • All-cause mortality
    • Myocardial infarction
    • Stent thrombosis
    • Stroke
    • Revascularisation
    • All bleeding requiring medical evaluation

    Measured: 3 years

Secondary outcomes (1)

  1. Number of participants with

    • mortality classification into cause-of-death (i.e cardiovascular, cardiac, vascular, cerebrovascular, death due to bleeding)
    • bleeding classification according to different bleeding criteria (i.e. TIMI, BARC, GUSTO, PLATO)
    • cessation (and duration) of antiplatelet therapy after ACS
    • patient related outcome measures, as reported in quality of life questionnaires (e.g. SF-12, Seattle Angina Questionnaires)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2019
  2. Study start1 Jan 2015
  3. Primary completion30 Jun 2050 (estimated)
  4. Study completion30 Jun 2050 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
99,999 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03823547
Sponsor's protocol ID
Hart Beter/FORCE-ACS
Acronym
FORCE-ACS
Status last verified
Jan 2019
First submitted
25 Jan 2019
Last updated
30 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • van den Broek WWA, Azzahhafi J, van de Pol QYF, Chan Pin Yin DRPP, van der Sangen NMR, Sivanesan S, Peper J, Harmsze AM, Walhout RJ, Tjon Joe Gin M, Breet NJ, Langerveld J, Appelman Y, van Schaik RHN, Henriques JPS, Kikkert WJ, Ten Berg JM. Genotype-Guided P2Y12-Inhibitor De-Escalation Strategy in Acute Coronary Syndrome: Observational Evidence From the POPular-GUIDE PCI. Circ Cardiovasc Interv. 2026 May;19(5):e016084. doi: 10.1161/CIRCINTERVENTIONS.125.016084. Epub 2026 Feb 26.

    PubMed 41744086

  • van den Broek WWA, Azzahhafi J, Chan Pin Yin DRPP, van der Sangen NMR, Sivanesan S, Dijksman LM, Walhout RJ, Tjon Joe Gin M, Breet NJ, Langerveld J, Vlachojannis GJ, van Bommel RJ, Appelman Y, van Schaik RHN, Henriques JPS, Kikkert WJ, Ten Berg JM. Cost-effectiveness of implementing a genotype-guided de-escalation strategy in patients with acute coronary syndrome. Eur Heart J Cardiovasc Pharmacother. 2025 May 2;11(3):230-240. doi: 10.1093/ehjcvp/pvae087.

    PubMed 39537191

  • van der Sangen NMR, Azzahhafi J, Chan Pin Yin DRPP, Peper J, Rayhi S, Walhout RJ, Tjon Joe Gin M, Nicastia DM, Langerveld J, Vlachojannis GJ, van Bommel RJ, Appelman Y, Henriques JPS, Ten Berg JM, Kikkert WJ. External validation of the GRACE risk score and the risk-treatment paradox in patients with acute coronary syndrome. Open Heart. 2022 Mar;9(1):e001984. doi: 10.1136/openhrt-2022-001984.

    PubMed 35354660

  • Chan Pin Yin DRPP, Vos GA, van der Sangen NMR, Walhout R, Tjon Joe Gin RM, Nicastia DM, Langerveld J, Claassens DMF, Gimbel ME, Azzahhafi J, Bor WL, Oirbans T, Dekker J, Vlachojannis GJ, van Bommel RJ, Appelman Y, Henriques JPS, Kikkert WJ, Ten Berg JM. Rationale and Design of the Future Optimal Research and Care Evaluation in Patients with Acute Coronary Syndrome (FORCE-ACS) Registry: Towards "Personalized Medicine" in Daily Clinical Practice. J Clin Med. 2020 Sep 30;9(10):3173. doi: 10.3390/jcm9103173.

    PubMed 33007932

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by J.M. ten Berg at 4 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dean R.P.P. Chan Pin Yin, MD (088 - 320 12 28, d.chanpinyin@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03823547, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.

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