Change of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome (CHANGE DAPT)
|ClinicalTrials.gov Identifier: NCT03197298|
Recruitment Status : Completed
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
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|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||2062 participants|
|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|
ACS patients treated by PCI with newer-generation DES before the guideline suggested change in primary DAPT-regimen
Other Name: Plavix
ACS patients treated by PCI with newer-generation DES after the guideline suggested change in primary DAPT-regimen
- Net adverse clinical and cerebral events (NACCE) [ Time Frame: 1 year ]A composite of all-cause death, any myocardial infarction, stroke, or major bleeding.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197298
|Medisch Spectrum Twente|
|Study Director:||Clemens von Birgelen, MD,PhD,Prof||Thoraxcentrum Twente|
|Principal Investigator:||K. Gert van Houwelingen, MD||Thoraxcentrum Twente|