Change of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome

Overview

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.

Full Title of Study: “Clopidogrel or Ticagrelor in Acute Coronary Syndrome Patients Treated With Newer-Generation Drug-Eluting Stents: CHANGE DAPT”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 25, 2016

Interventions

  • Drug: Clopidogrel
  • Drug: Ticagrelor

Arms, Groups and Cohorts

  • Clopidogrel Period
    • ACS patients treated by PCI with newer-generation DES before the guideline suggested change in primary DAPT-regimen
  • Ticagrelor Period
    • ACS patients treated by PCI with newer-generation DES after the guideline suggested change in primary DAPT-regimen

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • All-cause death
    • Time Frame: 1 year
    • All-cause mortality
  • Any myocardial infarction
    • Time Frame: 1 year
    • According to the Academic Research Consortium (ARC) definition
  • Stroke
    • Time Frame: 1 year
    • Focal loss of neurologic function caused by an ischemic or hemorrhagic event with residual symptoms lasting at least 24 hours or leading to death
  • Major Bleeding
    • Time Frame: 1 year
    • 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.
  • Any clinically indicated revascularization
    • Time Frame: 1 year
    • Revascularization by PCI or CABG
  • Stent thrombosis
    • Time Frame: 1 year
    • According to the Academic Research Consortium (ARC) definition

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Thorax Centrum Twente
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clemens von Birgelen, MD,PhD,Prof, Study Director, Thoraxcentrum Twente
    • K. Gert van Houwelingen, MD, Principal Investigator, Thoraxcentrum Twente

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