Change of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome (CHANGE DAPT)

Thorax Centrum Twente

Status: Completed

Conditions: Drug-Eluting Stents; Percutaneous Coronary Intervention; Acute Coronary Syndrome

Treatments: Drug: Ticagrelor; Drug: Clopidogrel

Study type: Observational

Funder types: Other

Identifiers

NCT03197298

K14-22

Details and patient eligibility

About

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.

Enrollment: 2,062 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,062 participants in 2 patient groups

Clopidogrel Period

Description:

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

Treatment:

Drug: Clopidogrel

Ticagrelor Period

Description:

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

Treatment:

Drug: Ticagrelor