search
Back to results

Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management (TICA KOREA)

Primary Purpose

Acute Coronary Syndrome, Myocardial Ischemia, Heart Diseases

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, coronary disease, coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Asan Medical Center
  • Chungnam National University Hospital
  • Keimyung University Dongsan Medical Center
  • Dongguk University Gyeongju Hospital
  • Inje University Ilsan Paik Hospital
  • Gachon University Gil Hospital
  • ChonBuk National University Hospital
  • Dong-A Medical Center
  • Inje University Pusan Paik Hospital
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor

Clopidogrel

Arm Description

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

The time to first occurrence of major bleeding event
by PLAtelet inhibition and patient Outcomes(PLATO) criteria
The time to first occurrence of minor bleeding event
by PLAtelet inhibition and patient Outcomes(PLATO) criteria
The time to first occurrence of major bleeding event or minor bleeding event
The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria
The time to first occurrence of major bleeding event
The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria
The time to first occurrence of minor bleeding event
The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria
The time to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding event from type 1 to type 5
By Bleeding Academic Research Consortium(BARC) Definition of Bleeding Events
The time of first occurrence of discontinuation of study medication from any bleeding event
Non serious adverse events
Adverse events following discontinuation of study medication
Serious adverse events
The time to first occurrence of death from vascular causes
Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of death from vascular causes
The time to first occurrence of myocardial infarction
Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of myocardial infarction
The time to first occurrence of stroke
Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of stroke
The time to occurrence of composite events
The time to occurrence of composite events(death from any cause, myocardial infarction, stroke)
The time to occurrence of death from any cause
Number of patients with net clinical benefit of any total bleeding and any event from the composite of death from vascular causes, Myocardial Infarction and stroke.

Full Information

First Posted
March 10, 2014
Last Updated
November 28, 2018
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT02094963
Brief Title
Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management
Acronym
TICA KOREA
Official Title
A Randomized, Open-label, Parallel Group, Multicenter Phase IV Study to Assess Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management:TICAKOREA Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 5, 2014 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Angina Pectoris
Keywords
acute coronary syndrome, coronary disease, coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Experimental
Arm Title
Clopidogrel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
180mg loading and 90mg bid
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
600mg loading and 75mg qd
Primary Outcome Measure Information:
Title
The time to first occurrence of any bleeding event
Description
Safety of Ticagrelor compared to Clopidogrel by measuring the time to first occurrence of any bleeding event(including major, minor bleedings)
Time Frame
1year
Title
The time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke
Description
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
Time Frame
1year
Secondary Outcome Measure Information:
Title
The time to first occurrence of major bleeding event
Description
by PLAtelet inhibition and patient Outcomes(PLATO) criteria
Time Frame
1year
Title
The time to first occurrence of minor bleeding event
Description
by PLAtelet inhibition and patient Outcomes(PLATO) criteria
Time Frame
1year
Title
The time to first occurrence of major bleeding event or minor bleeding event
Description
The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria
Time Frame
1year
Title
The time to first occurrence of major bleeding event
Description
The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria
Time Frame
1year
Title
The time to first occurrence of minor bleeding event
Description
The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria
Time Frame
1year
Title
The time to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding event from type 1 to type 5
Description
By Bleeding Academic Research Consortium(BARC) Definition of Bleeding Events
Time Frame
1year
Title
The time of first occurrence of discontinuation of study medication from any bleeding event
Time Frame
1year
Title
Non serious adverse events
Time Frame
1year
Title
Adverse events following discontinuation of study medication
Time Frame
1year
Title
Serious adverse events
Time Frame
1year
Title
The time to first occurrence of death from vascular causes
Description
Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of death from vascular causes
Time Frame
1year
Title
The time to first occurrence of myocardial infarction
Description
Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of myocardial infarction
Time Frame
1year
Title
The time to first occurrence of stroke
Description
Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of stroke
Time Frame
1year
Title
The time to occurrence of composite events
Description
The time to occurrence of composite events(death from any cause, myocardial infarction, stroke)
Time Frame
1year
Title
The time to occurrence of death from any cause
Time Frame
1year
Title
Number of patients with net clinical benefit of any total bleeding and any event from the composite of death from vascular causes, Myocardial Infarction and stroke.
Time Frame
1year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 and more Index event of non-ST or ST segment elevation ACS Provision of signed informed consent Exclusion Criteria: 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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Dae-jeon
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Dongguk University Gyeongju Hospital
City
Gyeongju
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
ChonBuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Dong-A Medical Center
City
Pusan
Country
Korea, Republic of
Facility Name
Inje University Pusan Paik Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is not a publicly funded trial.
Citations:
PubMed Identifier
31553203
Citation
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.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management

We'll reach out to this number within 24 hrs