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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug |
|
| |
| Ticagrelor |
| Measure | Description | Time Frame |
|---|---|---|
| Net adverse clinical and cerebral events (NACCE) | A composite of all-cause death, any myocardial infarction, stroke, or major bleeding. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | All-cause mortality | 1 year |
| Any myocardial infarction | According to the Academic Research Consortium (ARC) definition |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the primary cardiac care clinic of the Thoraxcentrum Twente
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| Name | Affiliation | Role |
|---|---|---|
| Clemens von Birgelen, MD,PhD,Prof | Thoraxcentrum Twente | Study Director |
| K. Gert van Houwelingen, MD | Thoraxcentrum Twente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Spectrum Twente | Enschede | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29151439 | Derived | Zocca P, van der Heijden LC, Kok MM, Lowik MM, Hartmann M, Stoel MG, Louwerenburg JW, de Man FHAF, Linssen GCM, Knottnerus IL, Doggen CJM, van Houwelingen KG, von Birgelen C. Clopidogrel or ticagrelor in acute coronary syndrome patients treated with newer-generation drug-eluting stents: CHANGE DAPT. EuroIntervention. 2017 Nov 20;13(10):1168-1176. doi: 10.4244/EIJ-D-17-00634. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Drug |
|
|
| 1 year |
| 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 |
| 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 |
| Any clinically indicated revascularization | Revascularization by PCI or CABG | 1 year |
| Stent thrombosis | According to the Academic Research Consortium (ARC) definition | 1 year |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |