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

Clopidogrel or Ticagrelor in Acute Coronary Syndrome Patients Treated With Newer-Generation Drug-Eluting Stents: CHANGE DAPT

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; Percutaneous Coronary Intervention; Drug-Eluting Stents
• Intervention / Treatment: Drug: Ticagrelor; Drug: Clopidogrel

• Study Type: Observational
• Enrollment (Actual): 2062

Contacts and Locations

Study Locations

• Netherlands
  • Enschede, Netherlands
    • Medisch Spectrum Twente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to the primary cardiac care clinic of the Thoraxcentrum Twente

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clopidogrel Period; ACS patients treated by PCI with newer-generation DES before the guideline suggested change in primary DAPT-regimen	Drug: Clopidogrel; Other Names: Plavix
Ticagrelor Period; ACS patients treated by PCI with newer-generation DES after the guideline suggested change in primary DAPT-regimen	Drug: Ticagrelor; Other Names: Brilinta; Brilique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net adverse clinical and cerebral events (NACCE)	A composite of all-cause death, any myocardial infarction, stroke, or major bleeding.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	All-cause mortality	1 year
Any myocardial infarction	According to the Academic Research Consortium (ARC) definition	1 year
Stroke	Focal loss of neurologic function caused by an ischemic or hemorrhagic event with residual symptoms lasting at least 24 hours or leading to death	1 year
Major Bleeding	Defined by Thrombolysis in Myocardial Infarction (TIMI) major bleeding or TIMI in the setting of coronary artery bypass grafting, and/or any Bleeding Academic Research Consortium (BARC) class 3 or 5.	1 year
Any clinically indicated revascularization	Revascularization by PCI or CABG	1 year
Stent thrombosis	According to the Academic Research Consortium (ARC) definition	1 year

Collaborators and Investigators

• Sponsor: Thorax Centrum Twente
• Investigators: Study Director: Clemens von Birgelen, MD,PhD,Prof, Thoraxcentrum Twente; Principal Investigator: K. Gert van Houwelingen, MD, Thoraxcentrum Twente

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2012
• Primary Completion (Actual): July 25, 2016
• Study Completion (Actual): July 25, 2016

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): June 23, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Ticagrelor; Percutaneous Coronary Intervention; clopidogrel; Acute Coronary Syndrome; Platelet Aggregation Inhibitors; Drug-Eluting Stents; Purinergic P2Y Receptor Antagonists
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Clopidogrel
• Other Study ID Numbers: K14-22