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Register:	EUCTR
Last refreshed on:	9 October 2012
Main ID:	EUCTR2006-000658-27-IT
Date of registration:	15/03/2007
Prospective Registration:	No
Primary sponsor:	ASTRAZENECA
Public title:
Scientific title:	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
Date of first enrolment:	02/02/2007
Target sample size:	18000
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000658-27
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
Phase:

Countries of recruitment
Austria	Czech Republic	Denmark	Finland	France	Germany	Greece	Hungary
Italy	Netherlands	Portugal	Spain	Sweden	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
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

Exclusion criteria:
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.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Acute Coronary Syndrome
MedDRA version: 6.1 Level: PT Classification code 10051592

Intervention(s)

Product Name: AZD6140
Product Code: AZD6140
Pharmaceutical Form: Tablet
CAS Number: 274693-27-5
Current Sponsor code: AZD6140
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: PLAVIX

Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: The primary objective of this study is to test the hypothesis that AZD6140 is superior to clopidogrel for the prevention of vascular events in patients with non-ST or ST elevation ACS. The primary efficacy endpoint is the time to first occurrence of any event from the composite of death from vascular causes, MI and stroke.

Secondary Objective: -The time to first occurrence of any event from the composite of death from vascular causes, MI and stroke for the subgroup of patients with intent for invasive management at randomisation planned coronary angiography with revascularisation if indicated during the index event hospitalisation -The time to first occurrence of any event from the composite of all-cause mortality, MI, and stroke -The time to first occurrence of any event from the composite of death from vascular causes, MI including silent MI by electrocardiogram ECG , stroke, severe recurrent cardiac ischaemia, recurrent cardiac ischaemia, transient ischaemic attack TIA and other arterial thrombotic events -The time to first occurrence of each component of the primary composite efficacy endpoint individually in the order of MI, death from vascular causes and then stroke -The time to occurrence of all-cause mortality -The other components of the secondary composite efficacy endpoints

Primary end point(s): The time to first occurrence of any event from the composite of death from vascular causes, MI and stroke. The primary safety endpoint is the time to first occurrence of any total major bleeding event.

Secondary Outcome(s)

Secondary ID(s)

D5130C05262

2006-000658-27-GB

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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