None listed
Conditions
Interventions
Drug : Ticagrelor 180mg loading and 90mg bid vs Clopidogrel 600mg loading and 75mg qd
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients =19 years of age 2. Index event of non-ST or ST segment elevation ACS, with an onset of symptoms during the previous 24 hours, for whom invasive management is planned, defined by: ? *For patients who had an ACS without ST-segment elevation, at least two of the following three criteria had to be met: 1) ST-segment changes on electrocardiography (ST-segment depression or transient elevation = 1 mm in two or more 2 contiguous leads), indicating ischemia; 2) A positive test of a biomarker (Troponin I or T or CK-MB greater than the upper limit of normal), indicating myocardial necrosis; or 3) One of several risk factors (age =60 years; previous myocardial infarction or coronary-artery bypass grafting [CABG]; coronary artery disease with stenosis of =50% in at least two vessels; previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization; diabetes mellitus; peripheral arterial disease; or chronic renal dysfunction, defined as a creatinine clearance of <60 ml per minute per 1.73 m2 of body surface area). ? *For patients who had an ACS with ST-segment elevation, the following two inclusion criteria had to be met: 1) Persistent ST-segment elevation of at least 0.1 mV in at least two contiguous leads or 2) A new left bundle-branch block, and the intention to perform primary PCI. 3. Voluntarily written informed consent prior to any study specific procedures.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to ticagrelor or aspirin 2. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin or long-term treatment with fondaparinux 3. Fibrinolytic therapy within 24 hours before randomization 4. Any condition which in the opinion of the Investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, active malignancy other than squamous cell or basal cell skin cancer, use of strong or moderate CYP2C19 inhibitors, including omeprazole and esomeprazole, long-term concomitant treatment with non-steroidal anti-inflammatory drugs [NSAIDs]) 5. Concomitant oral or IV therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice >1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin/rifampicin, phenytoin, carbamazepine) 6. Life expectancy <6 months based on investigator’s judgment 7. Dementia likely to jeopardise understanding of information pertinent to study conduct or compliance to study procedures 8. Severe hypertension that may put the patient at risk 9. Patients considered to be at risk of bradycardic events (e.g., known sick sinus syndrome or second or third degree atrioventricular [AV)] block) unless already treated with a permanent pacemaker 10. Known severe liver disease (eg, ascites and/or clinical signs of coagulopathy) 11. Renal failure requiring dialysis 12. A known bleeding diathesis, haemostatic or coagulation disorder, or systemic bleeding, whether resolved or ongoing 13. History of previous intracranial bleed at any time, gastrointestinal bleed within the past 6 months, or major surgery within 30 days (if the surgical wound is judged to be associated with an increased risk of bleeding) 14. History of thrombocytopenia or neutropenia 15. Females of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopause) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR females who have a positive pregnancy test at Visit 1. 16. Concern for inability of the patient to comply with study procedures and/or follow up (eg, alcohol or drug abuse) 17. Involvement in the planning and/or conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke;The time to first occurrence of any bleeding event | — |
Secondary
| Measure | Time frame |
|---|---|
| The time to first occurrence of major bleeding event by PLAtelet inhibition and patient Outcomes(PLATO) criteria;The time to first occurrence of minor bleeding event by PLAtelet inhibition and patient Outcomes(PLATO) criteria;The time to first occurrence of major bleeding event or minor bleeding event by The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria;The time to first occurrence of major bleeding event by The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria;The time to first occurrence of minor bleeding event by The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria;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;Non serious adverse events;Adverse events following discontinuation of study medication;Serious adverse events;The time to first occurrence of death from vascular causes;The time to first occurrence of myocardial infarction;The time to first occurrence of stroke;The time to occurrence of composite events ; death, myocardial infarction, stroke;The time to occurrence of death from any cause;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 | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung-jung Park
University of Ulsan
Outcome results
None listed