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TICAKOREA: Ticagrelor vs Clopidogrel in Korean ACS Patients
NCT02094963Phase 4
Key facts
- Status
- Completed
- Start
- Jul 2014
- Primary completion
- Nov 2018
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- ticagrelor
- Conditions
- acute coronary syndrome (ACS)
01
Overview
Phase 4, randomised, open-label trial of ticagrelor in acute coronary syndrome (ACS) (2 arms). Primary endpoints: The time to first occurrence of any bleeding event at 1 year and The time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke at 1 year. Started Jul 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Ticagrelor
Ticagrelor + Aspirin
Clopidogrel
Clopidogrel + Aspirin
03
Who it enrols
Asian/Korean patients aged 18 or older with non-ST or ST segment elevation ACS intended for invasive management. Excludes patients with hypersensitivity to aspirin or ticagrelor, severe liver disease, requiring dialysis, or increased bleeding risk.
04
Endpoints
Primary
The time to first occurrence of any bleeding event
The time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke
Secondary
The time to first occurrence of major bleeding event
The time to first occurrence of minor bleeding event
The time to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding event from type 1 to type 5
The time of first occurrence of discontinuation of study medication from any bleeding event
Serious adverse events
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
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