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

Sponsor

Yonsei University (Other)

Overall Status

Terminated

CT.gov ID

NCT02037412

Collaborator

(none)

148

Enrollment

Location

Arms

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Acute Myocardial Infarction Unstable Angina (Intermediate Coronary Syndrome)	Drug: Ticagrelor Drug: Clopidogrel	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Sep 30, 2016

Actual Study Completion Date :

Sep 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ticagrelor Arm Ticagrelor Arm	Drug: Ticagrelor Ticagrelor - 180 mg loading and 90 mg bid maintenance for 3 months
Active Comparator: Clopidogrel Arm Clopidogrel Arm	Drug: Clopidogrel Clopidogrel - 600 mg loading and 75 mg qd maintenance for 3 months

Arm

Intervention/Treatment

Experimental: Ticagrelor Arm

Ticagrelor Arm

Drug: Ticagrelor

Ticagrelor - 180 mg loading and 90 mg bid maintenance for 3 months

Active Comparator: Clopidogrel Arm

Clopidogrel Arm

Drug: Clopidogrel

Clopidogrel - 600 mg loading and 75 mg qd maintenance for 3 months

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.