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

Cardiovascular Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094963
• Other study ID #: AMCCV2013-14
• Status: Completed
• Phase: Phase 4
• Start date: July 5, 2014
• Est. completion date: November 1, 2018

Study information

• Verified date: November 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Cardiovascular Diseases
• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia
• Syndrome

Intervention

Drug:
• Ticagrelor
180mg loading and 90mg bid
• Clopidogrel
600mg loading and 75mg qd

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Dae-jeon
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Dongguk University Gyeongju Hospital	Gyeongju
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	ChonBuk National University Hospital	Jeonju
Korea, Republic of	Dong-A Medical Center	Pusan
Korea, Republic of	Inje University Pusan Paik Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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