Change of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome

Completed

• Conditions: Acute Coronary Syndrome; Percutaneous Coronary Intervention; Drug-Eluting Stents
• Interventions: Drug: Clopidogrel; Drug: Ticagrelor

• Registration Number: NCT03197298
• Lead Sponsor: Thorax Centrum Twente

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-21
• Primary Completion: 2016-07-25
• Study Completion: 2016-07-25
• Study First Submitted: 2017-05-23
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-22
• Last Update Submitted: 2017-06-22
• Study First Posted: 2017-06-23
• Last Update Posted: 2017-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2062

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clopidogrel Period	Clopidogrel	ACS patients treated by PCI with newer-generation DES before the guideline suggested change in primary DAPT-regimen
Ticagrelor Period	Ticagrelor	ACS patients treated by PCI with newer-generation DES after the guideline suggested change in primary DAPT-regimen

Primary Outcome Measures

Name	Time	Method
Net adverse clinical and cerebral events (NACCE)	1 year	A composite of all-cause death, any myocardial infarction, stroke, or major bleeding.

Secondary Outcome Measures

Name	Time	Method
Any clinically indicated revascularization	1 year	Revascularization by PCI or CABG
Any myocardial infarction	1 year	According to the Academic Research Consortium (ARC) definition
All-cause death	1 year	All-cause mortality
Stent thrombosis	1 year	According to the Academic Research Consortium (ARC) definition
Stroke	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	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.

Trial Locations

Locations (1)

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands