Clinical trial NCT03197298: Change of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome
Official title: Clopidogrel or Ticagrelor in Acute Coronary Syndrome Patients Treated With Newer-Generation Drug-Eluting Stents: CHANGE DAPT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Percutaneous Coronary Intervention
Drug-Eluting Stents
Keywords: Acute Coronary Syndrome
Percutaneous Coronary Intervention
Drug-Eluting Stents
Platelet Aggregation Inhibitors
Ticagrelor
clopidogrel
Purinergic P2Y Receptor Antagonists
Lead sponsor: Thorax Centrum Twente
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 2062
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the primary cardiac care clinic of the Thoraxcentrum Twente

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Net adverse clinical and cerebral events (NACCE)
timeFrame: 1 year
Secondary outcomes:
measure: All-cause death
timeFrame: 1 year
measure: Any myocardial infarction
timeFrame: 1 year
measure: Stroke
timeFrame: 1 year
measure: Major Bleeding
timeFrame: 1 year
measure: Any clinically indicated revascularization
timeFrame: 1 year
measure: Stent thrombosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
Study officials:
affiliation: Thoraxcentrum Twente
name: Clemens von Birgelen, MD,PhD,Prof
role: STUDY_DIRECTOR
affiliation: Thoraxcentrum Twente
name: K. Gert van Houwelingen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.