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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03197298
Other study ID # K14-22
Secondary ID
Status Completed
Phase N/A
First received May 23, 2017
Last updated June 22, 2017
Start date December 21, 2012
Est. completion date July 25, 2016

Study information

Verified date June 2017
Source Thorax Centrum Twente
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Clopidogrel

Ticagrelor


Locations

Country Name City State
Netherlands Medisch Spectrum Twente Enschede

Sponsors (1)

Lead Sponsor Collaborator
Thorax Centrum Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

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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