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

Acute Coronary Syndrome Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02037412
• Other study ID #: 4-2013-0764
• Status: Terminated
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: September 30, 2016

Study information

• Verified date: December 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 148
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ticagrelor
Ticagrelor - 180 mg loading and 90 mg bid maintenance for 3 months
• Clopidogrel
Clopidogrel - 600 mg loading and 75 mg qd maintenance for 3 months

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent re-endothelialization	Percentage of stent coverage measured by OCT	Three months after stent implantation
Primary	Neointimal hyperplasia	Neointimal thickness measured by OCT	Three months after stent implantation