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: non-ST and ST elevation acute coronary syndromes (ACS); MedDRA version: 8.1Level: HLTClassification code 10011085Term: Ischaemic coronary artery disorders

• Registration Number: EUCTR2006-000658-27-SE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-11
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18000

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

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. Known, clinically important thrombocytopenia
9. Known, clinically important anemia
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>- To assess the efficacy and safety of AZD6140 and clopidogrel in those patients<br>undergoing coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) during the study.<br>- To assess the occurrence of arrhythmic episodes detected by Holter monitoring during the initial period after randomization and at one month.<br>;Primary end point(s): Time to the first occurrence of any event from the composite of death from vascular causes(*), myocardial infarction and stroke.<br>(*): Death from vascular causes includes CV deaths, cerebrovascular deaths, and any other death for which there was no clearly documented non-vascular cause.