Acute Coronary Syndrome Clinical Trial
— CHANGE DAPTOfficial title:
Clopidogrel or Ticagrelor in Acute Coronary Syndrome Patients Treated With Newer-Generation Drug-Eluting Stents: CHANGE DAPT
Verified date | June 2017 |
Source | Thorax Centrum Twente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 2062 |
Est. completion date | July 25, 2016 |
Est. primary completion date | July 25, 2016 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Medisch Spectrum Twente | Enschede |
Lead Sponsor | Collaborator |
---|---|
Thorax Centrum Twente |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Net adverse clinical and cerebral events (NACCE) | A composite of all-cause death, any myocardial infarction, stroke, or major bleeding. | 1 year | |
Secondary | All-cause death | All-cause mortality | 1 year | |
Secondary | Any myocardial infarction | According to the Academic Research Consortium (ARC) definition | 1 year | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Any clinically indicated revascularization | Revascularization by PCI or CABG | 1 year | |
Secondary | Stent thrombosis | According to the Academic Research Consortium (ARC) definition | 1 year |
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