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

S

Seung-Jung Park

Status and phase

Completed
Phase 4

Conditions

Myocardial Ischemia
Acute Coronary Syndrome
Angina Pectoris
Cardiovascular Diseases
Heart Diseases

Treatments

Drug: Clopidogrel
Drug: Ticagrelor

Study type

Interventional

Funder types

Other

Identifiers

NCT02094963
AMCCV2013-14

Details and patient eligibility

About

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.

Enrollment

800 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

800 participants in 2 patient groups

Ticagrelor
Experimental group
Treatment:
Drug: Ticagrelor
Clopidogrel
Active Comparator group
Treatment:
Drug: Clopidogrel

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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