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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Angina Pectoris; Acute Coronary Syndrome
• Intervention / Treatment: Drug: Ticagrelor; Drug: Clopidogrel

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dae-jeon, Korea, Republic of
    • Chungnam National University Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Gyeongju, Korea, Republic of
    • Dongguk university gyeongju hospital
  • Ilsan, Korea, Republic of
    • Inje University Ilsan Paik Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Pusan, Korea, Republic of
    • Inje University Pusan Paik Hospital
  • Pusan, Korea, Republic of
    • Dong-A Medical Center
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 138-736
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clopidogrel	Drug: Clopidogrel; 600mg loading and 75mg qd
Experimental: Ticagrelor	Drug: Ticagrelor; 180mg loading and 90mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to first occurrence of major bleeding event	by PLAtelet inhibition and patient Outcomes(PLATO) criteria	1year
The time to first occurrence of minor bleeding event	by PLAtelet inhibition and patient Outcomes(PLATO) criteria	1year
The time to first occurrence of major bleeding event or minor bleeding event	The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria	1year
The time to first occurrence of major bleeding event	The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria	1year
The time to first occurrence of minor bleeding event	The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria	1year
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	1year
The time of first occurrence of discontinuation of study medication from any bleeding event		1year
Non serious adverse events		1year
Adverse events following discontinuation of study medication		1year
Serious adverse events		1year
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	1year
The time to first occurrence of myocardial infarction	Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of myocardial infarction	1year
The time to first occurrence of stroke	Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of stroke	1year
The time to occurrence of composite events	The time to occurrence of composite events(death from any cause, myocardial infarction, stroke)	1year
The time to occurrence of death from any cause		1year
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.		1year

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2014
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimate): March 24, 2014

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: coronary artery disease; coronary disease; acute coronary syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Vascular Diseases; Pain; Neurologic Manifestations; Disease; Chest Pain; Heart Diseases; Myocardial Ischemia; Cardiovascular Diseases; Syndrome; Ischemia; Acute Coronary Syndrome; Angina Pectoris; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Clopidogrel
• Other Study ID Numbers: AMCCV2013-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This is not a publicly funded trial.