Back to resultsImpact of Ticagrelor on the Endothelial Healing Following Drug-eluting Stent Implantation in the Patients With Acute Coronary Syndrome
Primary Purpose
Acute Coronary Syndrome, Acute Myocardial Infarction, Unstable Angina (Intermediate Coronary Syndrome)
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Ticagrelor, strut coverage, DES, ACS, OCT
Eligibility Criteria
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
Sites / Locations
- Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ticagrelor Arm
Clopidogrel Arm
Arm Description
Ticagrelor Arm
Clopidogrel Arm
Outcomes
Primary Outcome Measures
Stent re-endothelialization
Percentage of stent coverage measured by OCT
Neointimal hyperplasia
Neointimal thickness measured by OCT
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02037412
Brief Title
Impact of Ticagrelor on the Endothelial Healing Following Drug-eluting Stent Implantation in the Patients With Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
The patient registration was not successful.
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Acute Myocardial Infarction, Unstable Angina (Intermediate Coronary Syndrome)
Keywords
Ticagrelor, strut coverage, DES, ACS, OCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ticagrelor Arm
Arm Type
Experimental
Arm Description
Ticagrelor Arm
Arm Title
Clopidogrel Arm
Arm Type
Active Comparator
Arm Description
Clopidogrel Arm
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
Ticagrelor - 180 mg loading and 90 mg bid maintenance for 3 months
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel - 600 mg loading and 75 mg qd maintenance for 3 months
Primary Outcome Measure Information:
Title
Stent re-endothelialization
Description
Percentage of stent coverage measured by OCT
Time Frame
Three months after stent implantation
Title
Neointimal hyperplasia
Description
Neointimal thickness measured by OCT
Time Frame
Three months after stent implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
21071697
Citation
Patil SB, Jackman LE, Francis SE, Judge HM, Nylander S, Storey RF. Ticagrelor effectively and reversibly blocks murine platelet P2Y12-mediated thrombosis and demonstrates a requirement for sustained P2Y12 inhibition to prevent subsequent neointima. Arterioscler Thromb Vasc Biol. 2010 Dec;30(12):2385-91. doi: 10.1161/ATVBAHA.110.210732. Epub 2010 Nov 11.
Results Reference
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PubMed Identifier
19709765
Citation
Kim JS, Fan C, Choi D, Jang IK, Lee JM, Kim TH, Park SM, Paik SI, Ko YG, Hong MK, Jang Y, Chung N. Different patterns of neointimal coverage between acute coronary syndrome and stable angina after various types of drug-eluting stents implantation; 9-month follow-up optical coherence tomography study. Int J Cardiol. 2011 Feb 3;146(3):341-6. doi: 10.1016/j.ijcard.2009.07.012. Epub 2009 Aug 25.
Results Reference
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Impact of Ticagrelor on the Endothelial Healing Following Drug-eluting Stent Implantation in the Patients With Acute Coronary Syndrome
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