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

Phase 4

Completed

• Conditions: Acute Coronary Syndrome; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Angina Pectoris
• Interventions: Drug: Ticagrelor; Drug: Clopidogrel

• Registration Number: NCT02094963
• Lead Sponsor: Seung-Jung Park

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-24
• Study Start: 2014-07-05
• Status Verified: 2018-11
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-01
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticagrelor	Ticagrelor	-
Clopidogrel	Clopidogrel	-

Primary Outcome Measures

Name	Time	Method
The time to first occurrence of any bleeding event	1year	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	1year	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

Name	Time	Method
The time to first occurrence of stroke	1year	Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of stroke
Adverse events following discontinuation of study medication	1year
Serious adverse events	1year
The time to occurrence of composite events	1year	The time to occurrence of composite events(death from any cause, myocardial infarction, stroke)
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
The time to first occurrence of major bleeding event	1year	The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria
The time to first occurrence of major bleeding event or minor bleeding event	1year	The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria
The time to first occurrence of minor bleeding event	1year	The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria
The time to first occurrence of death from vascular causes	1year	Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of death from vascular causes
The time of first occurrence of discontinuation of study medication from any bleeding event	1year
The time to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding event from type 1 to type 5	1year	By Bleeding Academic Research Consortium(BARC) Definition of Bleeding Events
Non serious adverse events	1year
The time to first occurrence of myocardial infarction	1year	Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of myocardial infarction

Trial Locations

Locations (10)

Dong-A Medical Center; 🇰🇷 Pusan, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, 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

Inje University Pusan Paik Hospital; 🇰🇷 Pusan, Korea, Republic of