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OpenTrials
Completed

NCT Number: NCT03197298

Change of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Drug-Eluting Stents Heart Diseases Myocardial Ischemia Percutaneous Coronary Intervention Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medisch Spectrum Twente

Enschede, Netherlands

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

Other names: Plavix

Ticagrelor

Drug

Other names: Brilinta, Brilique

Primary outcomes

  1. 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 outcomes

  1. All-cause death

    Time frame: 1 year

    All-cause mortality

  2. Any myocardial infarction

    Time frame: 1 year

    According to the Academic Research Consortium (ARC) definition

  3. 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

  4. 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.

  5. Any clinically indicated revascularization

    Time frame: 1 year

    Revascularization by PCI or CABG

  6. Stent thrombosis

    Time frame: 1 year

    According to the Academic Research Consortium (ARC) definition

Sponsors and collaborators

Lead sponsor

Thorax Centrum Twente

Other

Registry information

Official study title

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

Acronym: CHANGE DAPT

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 23, 2017
Registry last updated
Jun 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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