Clinical trial NCT02094963: Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Keywords: acute coronary syndrome
coronary disease
coronary artery disease
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2014-03-24
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The time to first occurrence of any bleeding event
timeFrame: 1year
measure: The time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke
timeFrame: 1year
Secondary outcomes:
measure: The time to first occurrence of major bleeding event
timeFrame: 1year
measure: The time to first occurrence of minor bleeding event
timeFrame: 1year
measure: The time to first occurrence of major bleeding event or minor bleeding event
timeFrame: 1year
measure: The time to first occurrence of major bleeding event
timeFrame: 1year
measure: The time to first occurrence of minor bleeding event
timeFrame: 1year
measure: The time to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding event from type 1 to type 5
timeFrame: 1year
measure: The time of first occurrence of discontinuation of study medication from any bleeding event
timeFrame: 1year
measure: Non serious adverse events
timeFrame: 1year
measure: Adverse events following discontinuation of study medication
timeFrame: 1year
measure: Serious adverse events
timeFrame: 1year
measure: The time to first occurrence of death from vascular causes
timeFrame: 1year
measure: The time to first occurrence of myocardial infarction
timeFrame: 1year
measure: The time to first occurrence of stroke
timeFrame: 1year
measure: The time to occurrence of composite events
timeFrame: 1year
measure: The time to occurrence of death from any cause
timeFrame: 1year
measure: 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.
timeFrame: 1year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Dae-jeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Gyeongju
country: Korea, Republic of
facility: Dongguk University Gyeongju Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Jeonju
country: Korea, Republic of
facility: ChonBuk National University Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A Medical Center
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References:
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.