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

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seung-Jung Park
• Collaborator: CardioVascular Research Foundation, Korea
• Treatments: Clopidogrel; Ticagrelor; Ticlopidine

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