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

Yonsei University

Status and phase: Terminated; Phase 4

Conditions: Acute Coronary Syndrome; Unstable Angina (Intermediate Coronary Syndrome); Acute Myocardial Infarction

Treatments: Drug: Clopidogrel; Drug: Ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT02037412

4-2013-0764

Details and patient eligibility

About

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)

Enrollment: 148 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Ticagrelor Arm

Experimental group

Description:

Ticagrelor Arm

Treatment:

Drug: Ticagrelor

Clopidogrel Arm

Active Comparator group

Description:

Clopidogrel Arm

Treatment:

Drug: Clopidogrel