NCT02379676

Brief Summary

The purpose of this study is to compare the effects of ticagrelor and clopidogrel on endothelial dysfunction and vascular inflammation Ticagrelor will lead to beneficial pleiotropic effects compared with treatment with clopidogrel in patients receiving a drug-eluting stents (DES) during percutaneous coronary intervention (PCI) for non-ST-segment acute coronary syndrome (NSTE-ACS) beyond 1 month after the index event. Ticagrelor treatment will improve percent flow-mediated dilation (FMD) values and reduces inflammatory gene expression on peripheral blood mononuclear cells.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

February 28, 2015

Last Update Submit

July 3, 2016

Conditions

Endothelial DysfunctionVascular Inflammation

Outcome Measures

Primary Outcomes (1)

  • Change in percent flow-mediated dilation (FMD) values

    Baseline, 30 days

Secondary Outcomes (3)

  • Percent flow-mediated dilation (FMD) values

    Baseline, 30 days

  • Incidence rate of patient with percent flow-mediated dilation (FMD) value less than 7%

    Baseline, 30 days

  • Inflammatory gene expression levels by quantitative real-time reverse transcription-polymerase chain reaction (qRT-PCR)

    Baseline, 30 days

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Ticagrelor 90mg twice daily

Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel 75mg once daily

Drug: Clopidogrel

Interventions

TicagrelorDRUG

Ticagrelor 90mg twice daily for 30 days

Ticagrelor
ClopidogrelDRUG

Clopidogrel 75mg once daily for 30 days

Clopidogrel

Eligibility Criteria

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

You may qualify if:

  • Provision of informed consent prior to any study specific procedures
  • Men and women ≥20 years of age
  • Documented history of non-ST-segment acute coronary syndrome occurring 30 \~ 365 days prior to randomization and successfully treated with percutaneous coronary intervention using drug-eluting stent
  • Patient currently prescribed and tolerating aspirin 100mg and clopidogrel 75mg.
  • Patient who have demonstrated endothelial dysfunction defined as percent flow-mediated dilation values lower than 7% at baselines test

You may not qualify if:

  • Patients with angina related symptoms
  • Patients who did not undergo or failed invasive treatment
  • Patients with a history of hypersensitivity to ticagrelor or clopidogrel
  • Patients who took an anti-coagulant, anti-thrombotic regularly before the study, or plan to have continuous treatment during the study
  • Patients who took vasoactive agents or caffeine ingestion for \<48
  • Patients with decompensated congestive heart failure of cardiogenic shock (Killip classification III or IV)
  • Patients with intractable arrhythmia
  • Patients with intractable arrhythmia
  • Patients with second or third degree atrioventricular block
  • Patients with uncontrolled hypertension
  • Patients with high risk of hemorrhage like blood coagulation disorders, gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage
  • Patients with more than moderate chronic obstructive pulmonary disease diagnosed by symptoms or documented by pulmonary function test
  • Patients who required renal replacement therapy
  • Patients with moderate to severe hepatic impairment
  • Patients with platelet \<100,000/μL
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

TicagrelorClopidogrel

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Kiyuk Chang, MD, PhD

    Seoul St. Mary's Hospital, The Catholic.University of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiyuk Chang, MD, PhD

CONTACT

82-2-2258-1139kiyuk@catholic.ac.kr

Sungmin Lim, MD

CONTACT

82-2-2258-1139sungmin@catholic.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of the divison of cardiology

Study Record Dates

First Submitted

February 28, 2015

First Posted

March 5, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

July 6, 2016

Record last verified: 2016-07

Locations

KR(1)