A comparison of reduced-dose prasugrel and clopidogrel in elderly patients with acute coronary syndrome undergoing early PCI - The elderly-ACS 2 study

AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA0 个研究点目标入组 2,000 人开始时间: 2012年9月3日最近更新: 2022年3月14日

适应症

试验速览

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•Patients >74 years of age hospitalized for an ACS, with or without STE, with an onset of symptoms during the previous 48 hours, and candidates to an early PCI.
•Patients must be able to provide written informed consent before randomization.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) no
•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 2000

•History of stroke or TIA
•Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization.
•Hemoglobin level on admission <10 g/dl, unless this is considered to be secondary to renal dysfunction or known mielodysplasia.
•Secondary causes of acute myocardial ischemia.
•Known current platelet count < 90,000 cells/?L.
•Ongoing oral anticoagulant treatment or an INR known to be >1.5 at the time of screening.
•Concomitant severe obstructive lung disease, malignancy or neurologic deficit limiting follow-up or adherence to the study protocol.
•Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days prior to randomization
•Inhability to give at least verbal informed consent to the study.
•. Contraindications to the use of clopidogrel or prasugrel as per package leaflet

发起方

AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA