NCT02037412

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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
Last Updated

March 29, 2019

Status Verified

December 1, 2016

Enrollment Period

2.7 years

First QC Date

January 13, 2014

Last Update Submit

March 27, 2019

Conditions

Acute Coronary SyndromeAcute Myocardial InfarctionUnstable Angina (Intermediate Coronary Syndrome)

Keywords

Ticagrelorstrut coverageDESACSOCT

Outcome Measures

Primary Outcomes (2)

  • Stent re-endothelialization

    Percentage of stent coverage measured by OCT

    Three months after stent implantation

  • Neointimal hyperplasia

    Neointimal thickness measured by OCT

    Three months after stent implantation

Study Arms (2)

Ticagrelor Arm

EXPERIMENTAL

Ticagrelor Arm

Drug: Ticagrelor

Clopidogrel Arm

ACTIVE COMPARATOR

Clopidogrel Arm

Drug: Clopidogrel

Interventions

TicagrelorDRUG

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

Ticagrelor Arm
ClopidogrelDRUG

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

Clopidogrel Arm

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 20 years old
  • Patients who are hospitalized and expected to undergo PCI for acute coronary syndrome, including acute myocardial infarction and unstable angina.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 21071697BACKGROUND

  • 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.

    PMID: 19709765BACKGROUND

MeSH Terms

Conditions

Acute Coronary SyndromeAngina, Unstable

Interventions

TicagrelorClopidogrel

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 15, 2014

Study Start

January 1, 2014

Primary Completion

September 30, 2016

Study Completion

September 30, 2016

Last Updated

March 29, 2019

Record last verified: 2016-12

Locations

KR(1)