non-ST and ST elevation acute coronary syndromes (ACS) MedDRA version: 9 Level: HLT Classification code 10011085
Conditions
Interventions
Product Code: AZD6140 90 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ticagrelor
CAS Number: 274693-27-5
Current Spon
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Index event of non-ST or ST segment elevation ACS. The patient should be hospitalised for chest pain and potential ACS and the onset of the most recent cardiac ischaemic symptoms of the index event must occur within the 24 hours before randomisation and be documented by cardiac ischaemic symptoms of =10 minutes duration at rest AND (i, ii, or iii): i) Persistent ST segment elevation =1mm (0.1 mV) in 2 or more contiguous leads and primary PCI planned OR ii) New or presumed new left bundle branch block (LBBB) and primary PCI planned OR iii) Cardiac ischaemic symptoms of =10 minutes duration at rest and at least 2 of the following 3 criteria (A-C): A) ST segment changes on ECG indicative of ischaemia: B) Positive biomarker (Troponin I or -T or CK-MB) evidence of myocardial necrosis: C) Having at least one of the following risk factors: Aged 60 or over, Previous MI or CABG, Known multi-vessel coronary artery disease (CAD), Previous ischaemic stroke, TIA, carotid stenosis, or cerebral revascularisation, Diabetes mellitus, Peripheral arterial disease, Chronic renal dysfunction 2. Provision of signed informed consent form. 3. Male or female aged at least 18 years 4. Females of child-bearing potential who are willing to use 2 methods of contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Contraindication or other reason that clopidogrel or AZD6140 should not be administered. 2. Index event is a complication of PCI 3. Patient has undergone PCI after the index event and before the first dose of study treatment 4. Oral anticoagulation therapy that cannot be stopped 5. Fibrinolytic therapy in the 24 hours prior to randomisation, or planned fibrinolytic treatment following randomisation 6. Increased risk of bradycardic events 7. Patient requires dialysis 8. Platelet count less than 100 x 10E9/L 9. Haemoglobin (Hb) level less than 100 g/L 10. Participation in another investigational drug or device study in the last 30 days 11. Pregnancy or lactation 12. Concomitant oral or intravenous therapy with strong CYP 3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers which cannot be stopped for the course of the study 13. Any other condition which in the opinion of the investigator, may either put the patient at risk or influence the result of the study 14. Involvement in the planning and conduct of the study 15. Previous enrolment or randomisation of treatment in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test that AZD6410 is superior to clopidogrel for prevention of vascular events (death from vascular causes, MI, stroke) in patients with non-ST or ST elevation acute coronary syndromes (ACS).; Secondary Objective: - To assess the safety and tolerability of AZD6140 compared to clopidogrel. - To assess the efficacy and safety of AZD6140 and clopidogrel in those patients undergoing coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) during the study. - To assess the occurrence of arrhythmic episodes detected by Holter monitoring during the initial period after randomization and at one month. ;Primary end point(s): Time to the first occurrence of any event from the composite of death from vascular causes, myocardial infarction and stroke. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Portugal, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed