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

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ClinicalTrials.gov Identifier: NCT03197298
Recruitment Status : Completed
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Thorax Centrum 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.


Condition or disease Intervention/treatment
Acute Coronary Syndrome Percutaneous Coronary Intervention Drug-Eluting Stents Drug: Clopidogrel Drug: Ticagrelor

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2062 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Clopidogrel or Ticagrelor in Acute Coronary Syndrome Patients Treated With Newer-Generation Drug-Eluting Stents: CHANGE DAPT
Actual Study Start Date : December 21, 2012
Actual Primary Completion Date : July 25, 2016
Actual Study Completion Date : July 25, 2016

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients admitted to the primary cardiac care clinic of the Thoraxcentrum Twente
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197298


Locations
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Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Sponsors and Collaborators
Thorax Centrum Twente
Investigators
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Study Director: Clemens von Birgelen, MD,PhD,Prof Thoraxcentrum Twente
Principal Investigator: K. Gert van Houwelingen, MD Thoraxcentrum Twente

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thorax Centrum Twente
ClinicalTrials.gov Identifier: NCT03197298     History of Changes
Other Study ID Numbers: K14-22
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017

Keywords provided by Thorax Centrum Twente:
Acute Coronary Syndrome
Percutaneous Coronary Intervention
Drug-Eluting Stents
Platelet Aggregation Inhibitors
Ticagrelor
clopidogrel
Purinergic P2Y Receptor Antagonists

Additional relevant MeSH terms:
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Clopidogrel
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs