NCT02094963

Brief Summary

The purpose of this study is to assess safety and efficacy of Ticagrelor versus Clopidogrel in Asian/KOREAn patients with acute coronary syndromes intended for invasive management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

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

First Submitted

Initial submission to the registry

March 10, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 5, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 30, 2018

Status Verified

November 1, 2018

Enrollment Period

4.3 years

First QC Date

March 10, 2014

Last Update Submit

November 28, 2018

Conditions

Acute Coronary SyndromeMyocardial IschemiaHeart DiseasesCardiovascular DiseasesAngina Pectoris

Keywords

acute coronary syndromecoronary diseasecoronary artery disease

Outcome Measures

Primary Outcomes (2)

  • The time to first occurrence of any bleeding event

    Safety of Ticagrelor compared to Clopidogrel by measuring the time to first occurrence of any bleeding event(including major, minor bleedings)

    1year

  • The time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke

    Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke

    1year

Secondary Outcomes (16)

  • The time to first occurrence of major bleeding event

    1year

  • The time to first occurrence of minor bleeding event

    1year

  • The time to first occurrence of major bleeding event or minor bleeding event

    1year

  • The time to first occurrence of major bleeding event

    1year

  • The time to first occurrence of minor bleeding event

    1year

  • +11 more secondary outcomes

Study Arms (2)

Ticagrelor

EXPERIMENTAL
Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR
Drug: Clopidogrel

Interventions

TicagrelorDRUG

180mg loading and 90mg bid

Ticagrelor
ClopidogrelDRUG

600mg loading and 75mg qd

Clopidogrel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and more
  • Index event of non-ST or ST segment elevation ACS
  • Provision of signed informed consent

You may not qualify if:

  • Hypersensitivity to aspirin or ticagrelor
  • Oral anticoagulation therapy that cannot be stopped
  • Treated with thrombolysis within 24hrs
  • Any other reason the investigator deems the subject to be unsuitable for the study e.g., Active malignant tumor
  • Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers
  • Any life-threatening condition with life expectancy less than 6months
  • Mental condition (dementia, alcohol or drug abuse) which may be affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study
  • High risk due to malignant hypertension
  • The conditions associated with increased risk of bradycardiac events
  • Subjects with severe liver disease
  • Subjects requiring dialysis
  • Increased bleeding risk
  • History of cerebral hemorrhage, gastrointestinal bleeding within 6months, major surgical procedure within 30days
  • Thrombocytopenia or leukopenia
  • Positive pregnancy test or is known to be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Dongguk University Gyeongju Hospital

Gyeongju, South Korea

Location

Inje University Ilsan Paik Hospital

Ilsan, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

ChonBuk National University Hospital

Jeonju, South Korea

Location

Dong-A Medical Center

Pusan, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Related Publications (4)

  • Jang MH, Kim AR, Kim T, Oh HJ, Lee JH, Lee YJ, Kim S, Lee J, Kim JH, Cha SJ, Kim TO, Kang DY, Lee PH, Ahn JM, Park DW, Park SJ; TICAKOREA Investigators. Age- and Sex-Specific Disparities in Outcomes After Ticagrelor Versus Clopidogrel in East Asian Patients. Am J Cardiol. 2023 Nov 15;207:237-244. doi: 10.1016/j.amjcard.2023.08.124. Epub 2023 Sep 26.

    PMID: 37757520DERIVED

  • Lee J, Kim MJ, Kim M, Park J, Kim H, Cho S, Choi Y, Lee J, Kim JH, Cha SJ, Kim TO, Kang DY, Lee PH, Ahn JM, Park SJ, Park DW; TICAKOREA Study Investigators. Validation of Academic Research Consortium for High Bleeding Risk Definition in East-Asian Patients. JACC Asia. 2023 Feb 7;3(3):390-399. doi: 10.1016/j.jacasi.2022.11.012. eCollection 2023 Jun.

    PMID: 37323862DERIVED

  • Choi Y, Kang DY, Lee J, Lee J, Kim M, Kim H, Park J, Cho S, Lee J, Cha SJ, Kim TO, Lee PH, Ahn JM, Park SJ, Park DW; TICA KOREA Investigators. Ticagrelor Versus Clopidogrel in East Asian Patients With Acute Coronary Syndrome and Diabetes Mellitus. JACC Asia. 2022 Nov 15;2(6):666-674. doi: 10.1016/j.jacasi.2022.07.005. eCollection 2022 Nov.

    PMID: 36444315DERIVED

  • Park DW, Kwon O, Jang JS, Yun SC, Park H, Kang DY, Ahn JM, Lee PH, Lee SW, Park SW, Choi SW, Lee SG, Yoon HJ, Ahn T, Kim MH, Nah DY, Lee SY, Chae JK, Park SJ; TICAKOREA Investigators. Clinically Significant Bleeding With Ticagrelor Versus Clopidogrel in Korean Patients With Acute Coronary Syndromes Intended for Invasive Management: A Randomized Clinical Trial. Circulation. 2019 Dec 3;140(23):1865-1877. doi: 10.1161/CIRCULATIONAHA.119.041766. Epub 2019 Sep 25.

    PMID: 31553203DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial IschemiaHeart DiseasesCardiovascular DiseasesAngina PectorisCoronary DiseaseCoronary Artery Disease

Interventions

TicagrelorClopidogrel

Condition Hierarchy (Ancestors)

Vascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive Diseases

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 INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 24, 2014

Study Start

July 5, 2014

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 30, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

This is not a publicly funded trial.

Locations

KR(10)