Impact of Ticagrelor on the Endothelial Healing Following Drug-eluting Stent Implantation in the Patients With Acute Coronary Syndrome

Phase 4

Terminated

• Conditions: Unstable Angina (Intermediate Coronary Syndrome); Acute Coronary Syndrome; Acute Myocardial Infarction
• Interventions: Drug: Ticagrelor; Drug: Clopidogrel

• Registration Number: NCT02037412
• Lead Sponsor: Yonsei University

Brief Summary

The investigators hypothesized that ticagrelor may enhance endothelial healing after DES implantation by increasing adenosine concentrations by the inhibition of adenosine uptake into erythrocytes, compared to clopidogrel. Thus, the investigators will evaluate the extent of endothelialization (stent strut coverage) and neointimal hyperplasia (neointimal thickness) 3 months after DES implantation by optical coherence tomography (OCT)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-15
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Status Verified: 2016-12
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Patients ≥ 20 years old
• Patients who are hospitalized and expected to undergo PCI for acute coronary syndrome, including acute myocardial infarction and unstable angina.

Exclusion Criteria

• Age > 80 years
• Cardiogenic shock or unstable patients
• Increased risk of bleeding, anemia, thrombocytopenia
• A need for oral anticoagulation therapy
• Pregnant women or women with potential childbearing
• Life expectancy < 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticagrelor Arm	Ticagrelor	Ticagrelor Arm
Clopidogrel Arm	Clopidogrel	Clopidogrel Arm

Primary Outcome Measures

Name	Time	Method
Stent re-endothelialization	Three months after stent implantation	Percentage of stent coverage measured by OCT
Neointimal hyperplasia	Three months after stent implantation	Neointimal thickness measured by OCT

Trial Locations

Locations (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of