Change of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— CHANGE DAPT  

Official title:

Clopidogrel or Ticagrelor in Acute Coronary Syndrome Patients Treated With Newer-Generation Drug-Eluting Stents: CHANGE DAPT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197298
• Other study ID #: K14-22
• 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
• 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
• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Drug-Eluting Stents
• Percutaneous Coronary Intervention
• Syndrome

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