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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-05

Study Completion Date

2018-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ticagrelor

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

180mg loading and 90mg bid

Clopidogrel

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

600mg loading and 75mg qd

Interventions

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Ticagrelor

180mg loading and 90mg bid

Intervention Type DRUG

Clopidogrel

600mg loading and 75mg qd

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No