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Completed

NCT Number: NCT02094963

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

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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Key information

Conditions

Acute Coronary Syndrome Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center, Seoul, Songpa-gu, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

180mg loading and 90mg bid

clopidogrel

Drug

600mg loading and 75mg qd

Primary outcomes

  1. The time to first occurrence of any bleeding event

    Time frame: 1year

    Safety of Ticagrelor compared to Clopidogrel by measuring the time to first occurrence of any bleeding event(including major, minor bleedings)

  2. The time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke

    Time frame: 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 outcomes

  1. The time to first occurrence of major bleeding event

    Time frame: 1year

    by PLAtelet inhibition and patient Outcomes(PLATO) criteria

  2. The time to first occurrence of minor bleeding event

    Time frame: 1year

    by PLAtelet inhibition and patient Outcomes(PLATO) criteria

  3. The time to first occurrence of major bleeding event or minor bleeding event

    Time frame: 1year

    The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria

  4. The time to first occurrence of major bleeding event

    Time frame: 1year

    The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria

  5. The time to first occurrence of minor bleeding event

    Time frame: 1year

    The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria

  6. The time to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding event from type 1 to type 5

    Time frame: 1year

    By Bleeding Academic Research Consortium(BARC) Definition of Bleeding Events

  7. The time of first occurrence of discontinuation of study medication from any bleeding event

    Time frame: 1year

  8. Non serious adverse events

    Time frame: 1year

  9. Adverse events following discontinuation of study medication

    Time frame: 1year

  10. Serious adverse events

    Time frame: 1year

  11. The time to first occurrence of death from vascular causes

    Time frame: 1year

    Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of death from vascular causes

  12. The time to first occurrence of myocardial infarction

    Time frame: 1year

    Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of myocardial infarction

  13. The time to first occurrence of stroke

    Time frame: 1year

    Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of stroke

  14. The time to occurrence of composite events

    Time frame: 1year

    The time to occurrence of composite events(death from any cause, myocardial infarction, stroke)

  15. The time to occurrence of death from any cause

    Time frame: 1year

  16. 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.

    Time frame: 1year

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study 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

Acronym: TICA KOREA

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 24, 2014
Registry last updated
Nov 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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