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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-09-30

Brief Summary

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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)

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Detailed Description

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Conditions

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Acute Coronary Syndrome Acute Myocardial Infarction Unstable Angina (Intermediate Coronary Syndrome)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ticagrelor Arm

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

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

Clopidogrel Arm

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

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

Interventions

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Ticagrelor

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

Intervention Type DRUG

Clopidogrel

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No