Change of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome

NCT ID: NCT03197298

Last Updated: 2017-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2062 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-21

Study Completion Date

2016-07-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Acute coronary syndrome (ACS) guidelines have been changed, favoring dual antiplatelet therapy (DAPT) with the more potent P2Y12 inhibitor ticagrelor over clopidogrel (besides aspirin). This change is based on studies that showed benefits of ticagrelor. However, study participants were only partly treated by percutaneous coronary intervention (PCI). In patients who were treated by PCI, this was generally performed using of bare metal or first-generation drug-eluting stents (DES).

CHANGE DAPT is an investigator-initiated, prospective, single centre registry, in which we evaluate the impact of the guideline suggested change in the primary DAPT regimen (from clopidogrel to ticagrelor) on 1-year clinical outcome in ACS patients treated by PCI with newer-generation DES in the Thoraxcentrum Twente.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Coronary Syndrome Percutaneous Coronary Intervention Drug-Eluting Stents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clopidogrel Period

ACS patients treated by PCI with newer-generation DES before the guideline suggested change in primary DAPT-regimen

Clopidogrel

Intervention Type DRUG

Ticagrelor Period

ACS patients treated by PCI with newer-generation DES after the guideline suggested change in primary DAPT-regimen

Ticagrelor

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clopidogrel

Intervention Type DRUG

Ticagrelor

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Plavix Brilinta Brilique

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Presentation with acute coronary syndrome (ACS)
* Treated with newer-generation drug-eluting stent (DES) in coronary artery or bypass graft lesion

Exclusion Criteria

* Known pregnancy
* Life expectancy less than one year
* Planned elective surgery requiring interruption of DAPT in the first 6 months
* Known intolerance to components of the DES available
* Indication for oral anticoagulation at baseline
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Thorax Centrum Twente

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clemens von Birgelen, MD,PhD,Prof

Role: STUDY_DIRECTOR

Thoraxcentrum Twente

K. Gert van Houwelingen, MD

Role: PRINCIPAL_INVESTIGATOR

Thoraxcentrum Twente

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medisch Spectrum Twente

Enschede, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

Zocca P, van der Heijden LC, Kok MM, Lowik MM, Hartmann M, Stoel MG, Louwerenburg JW, de Man FHAF, Linssen GCM, Knottnerus IL, Doggen CJM, van Houwelingen KG, von Birgelen C. Clopidogrel or ticagrelor in acute coronary syndrome patients treated with newer-generation drug-eluting stents: CHANGE DAPT. EuroIntervention. 2017 Nov 20;13(10):1168-1176. doi: 10.4244/EIJ-D-17-00634.

Reference Type DERIVED
PMID: 29151439 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K14-22

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy and Safety of Low-dose Ticagrelor
NCT03381742 COMPLETED PHASE2/PHASE3