NCT03823547

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99,999

participants targeted

Target at P75+ for all trials

Timeline
293mo left

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jan 2015Jun 2050

Study Start

First participant enrolled

January 1, 2015

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
31.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2050

Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

35.5 years

First QC Date

January 25, 2019

Last Update Submit

January 29, 2019

Conditions

Keywords

DAPTDual Antiplatelet TherapyMyocardial infarctionAcute Coronary SyndromeTicagrelorPrasugrelClopidogrelThrombosisMyocardial IschemiaPlatelet aggregation inhibitorsRisk scoresCardiovascular diseases

Outcome Measures

Primary Outcomes (1)

  • Number of participants with

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

    3 years

Secondary Outcomes (1)

  • Number of participants with

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • All patients presenting with ACS
  • Age ≥ 18 years

You may not qualify if:

  • No oral or signed informed consent available.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Gelre Ziekenhuizem

Apeldoorn, Gelderland, 7334 DZ, Netherlands

RECRUITING

Rijnstate Arnhem

Arnhem, Gelderland, 6815 AD, Netherlands

RECRUITING

Gelderse Vallei

Ede, Gelderland, 6716 RP, Netherlands

RECRUITING

Ziekenhuis Rivierenland

Tiel, Gelderland, 4002 WP, Netherlands

RECRUITING

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial InfarctionThrombosisMyocardial IschemiaCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisEmbolism and Thrombosis

Study Officials

  • Johan Dekker, Drs.

    St. Antonius Hospital

    STUDY CHAIR

Central Study Contacts

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

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 30, 2019

Study Start

January 1, 2015

Primary Completion (Estimated)

June 30, 2050

Study Completion (Estimated)

June 30, 2050

Last Updated

January 30, 2019

Record last verified: 2019-01

Locations