POISE-2 TrialPeriOperative ISchemic Evaluation-2 TrialA large, international, placebo-controlled, factorial trial to assess the impact of clonidine and acetyl-salicylic acid (ASA) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event - POISE-2

Population Health Research Institute0 个研究点目标入组 10,000 人开始时间: 2010年8月10日最近更新: 2015年7月10日

试验速览

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•1.Are undergoing noncardiac surgery;
•2.Are > 45 years of age;
•3.Are expected to require at least an overnight hospital admission after surgery; AND
•4.Fulfill one or more of the following 5 criteria:
•A.History of coronary artery disease;
•B.History of peripheral vascular disease;
•C.History of stroke;
•D.Undergoing major vascular surgery; or
•E.Any 3 of the following 9 criteria: undergoing major surgery (i.e. intraperitoneal, intrathoracic, or major orthopedic surgery), history of congestive heart failure, transient ischemic attack, diabetes and currently taking an oral hypoglycemic agent or insulin, age > 70 years, hypertension, serum creatinine > 175 µmol/L (> 2.0 mg/dL), history of smoking within 2 years of surgery, undergoing urgent/emergent surgery
•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.Consumption of ASA within 72 hours prior to surgery;
•2.Hypersensitivity or known allergy to ASA or clonidine;
•3.Systolic blood pressure < 105 mm Hg;
•4.Heart rate < 55 beats per minute in a patient who does not have a permanent pacemaker;
•5.Second or third degree heart block without a permanent pacemaker;
•6.Active peptic ulcer disease or gastrointestinal bleeding within previous 6 weeks;
•7.Intracranial hemorrhage documented by neuro-imaging, in the 6 months prior to randomization. This does not include petechial hemorrhagic transformation of a primary ischemic stroke;
•8.Subarachnoid hemorrhage or epidural hematoma unless the event occurred more than 6 months prior to randomization and the offending aneurysm or arterial lesion has been repaired;
•9.Drug-eluting coronary stent in the year prior to randomization;
•10.Bare-metal coronary stent in the 6 weeks prior to randomization;
•11.Currently taking an alpha-2 agonist, alpha methyldopa, reserpine, ticagrelor, or thienopyridine;
•12.Planned use – during the first 3 days after surgery – therapeutic dose anticoagulation or a therapeutic subcutaneous or intravenous antithrombotic agent;
•13.Undergoing intracranial surgery, carotid endarterectomy, or retinal surgery;
•14.Not consenting to participate in POISE-2 prior to surgery;
•15.Previously enrolled in POISE-2 Trial

发起方