Eptifibatide Versus Abciximab in primary PCI for Acute ST elevation Myocardial Infarction (EVA-AMI) - EVA-AMI

GlaxoSmithKline Research, European Medical Governance0 个研究点目标入组 400 人开始时间: 2006年7月25日最近更新: 2012年3月19日

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•1.Male or female subject = 18 years of age. Women must be postmenopausal (i.e.12 months without menstrual period), or surgically sterile, i.e. women of child bearing potential are not allowed to be included into the study. In cases of doubt a pregnancy test should be performed. (NB -post menopausal women currently receiving hormone replacement are permissible)
•2.Acute myocardial infarction < 12 h defined as:
•a.Angina or equivalent symptoms > 20 min and
•b.ST elevation in 2 contiguous ECG leads (= 2 mm precordial lead, = 1 mm limb lead). This ECG recording serves as baseline ECG, i.e. ECG I.
•3.planned primary percutaneous coronary intervention
•4.The subject has given written informed, dated consent to participate in the study
•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

•1. Subjects not able to give informed consnet
•2.Left Bundle Branch Block
•3.Thrombolytic therapy within 24 hours before randomization
•4.Oral anticoagulation with INR > 2
•5.Known platelets < 100.000/µl or known hemorrhagic diathesis
•6.Stroke or TIA within the past 6 months or any permanent residual neurological defect
•7.Evidence of an active gastrointestinal or urogenital bleeding
•8.Major surgery within 6 weeks
•9.History of allergic reaction to abciximab or eptifibatide or any component used in the study (including contrast media)
•10.Known severe renal (creatinine clearance <30ml/min) or hepatic insufficiency as well as ALT/AST elevations = 3xULN; isolated AST-elevation is not considered an exclusion criteria from study participitation.
•11.Severe concomitant disease with life expectation < 1 year
•12.Subject has participated in any study using an investigational drug or device within 30 days or within 5 half-lives of the investigational drug (whichever is longer) of entry into this study.
•13.Subjects who will be inaccessible due to geographic or social factors during treatment or follow-up
•14.In France, a subject is neither affiliated with nor a beneficiary of a social security category.

发起方

GlaxoSmithKline Research, European Medical Governance