A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of AZD6140 Compared with Clopidogrel for Prevention of Vascular Events in Patients with Non-ST or ST Elevation Acute Coronary Syndromes ACS PLATO A Study of PLATelet inhibition and Patient Outcomes. - PLATO
- Conditions
- MedDRA version: 6.1Level: PTClassification code 10051592Acute Coronary Syndrome
- Registration Number
- EUCTR2006-000658-27-IT
- Lead Sponsor
- ASTRAZENECA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18000
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 symptomsa of 8805;10 minutes duration at rest and Persistent ST segment elevationc 8805;1mm 0.1 mV in 2 or more contiguous leads and primary PCI planned or New or presumed new left bundle branch block LBBB and primary PCI planned or Cardiac ischaemic symptomsa of 8805;10 minutes duration at restb and at least 2 of the following criteria i ST segment changes on ECG indicative of ischaemia Either ST segment depressiond 8805;1mm 0.1mV in 2 or more contiguous leads or Transient ST segment elevationc 8805;1 mm 0.1 mV in 2 or more contiguous leads ii Positive biomarker evidence of myocardial necrosis Either Troponin T or I greater than the laboratory upper normal limite on at least one occasion in association with the index clinical event ie, any elevated troponin level or CK-MB, preferably CK-MB mass, greater than the laboratory upper normal limite on at least one occasion in association with the index clinical event iii Having at least one of the following risk factors Aged 60 or over Previous MI or CABG Known multi-vessel coronary artery disease CAD 50 or more stenosis in 2 or more vessels Previous ischaemic stroke, TIA hospital based diagnosis , carotid stenosis 50 or more or cerebral revascularisation Diabetes mellitus Peripheral arterial disease intermittent claudication with prior objective confirmation, previous revascularisation or ankle-brachial index less than 0.9 Chronic renal dysfunction creatinine clearance calculated by Cockcroft Gault equation is less than 60 mL/min . Provision of signed informed consent form. Male or female aged at least 18 years Females of child-bearing potential ie, females who are not chemically or surgically sterilised or females who are not post-menopause must have a negative urine or blood pregnancy test at enrolment and be willing to use 2 methods of reliable contraception, one of which must be a barrier method
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
Any of the following is regarded as a criterion for exclusion from the study Contraindication or other reason that clopidogrel or AZD6140 should not be administered eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, GI bleed within the past 6 months, major surgery within 30 days Index event is an acute complication of PCI Patient has undergone PCI after the index event and before the first dose of study treatment Oral anticoagulation therapy that cannot be stopped ie, patient requires chronic therapy Fibrinolytic therapy in the 24 hours prior to randomisation, or planned fibrinolytic treatment following randomisation eg, for STEMI or PE Increased risk of bradycardic events e.g. no pacemaker and known sick sinus syndrome, second degree A-V block, third degree A-V block or previous documented syncope suspected to be due to bradycardia . The DSMB will review the Holter data in this study to assess the need to continue with this exclusion. Patient requires dialysis Platelet count less than 100 x 109/L Haemoglobin Hb level less than 100 g/L Participation in another investigational drug or device study in the last 30 days Pregnancy or lactation Concomitant oral or intravenous therapy see examples below with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers which cannot be stopped for the course of the study Strong inhibitors ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, over 1 litre daily of grapefruit juice. Substrates with narrow therapeutic index cyclosporine, quinidine. Strong inducers rifampin/rifampicin, phenytoin, carbamazepine. Any other condition which in the opinion of the investigator, may either put the patient at risk or influence the result of the study eg, cardiogenic shock or severe haemodynamic instability, active cancer, risk for non-compliance, risk for being lost to follow up Involvement in the planning and conduct of the study applies to both AstraZeneca staff or staff at the study site Previous enrolment or randomisation of treatment in the present study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method