PER-111-10已完成未知
A 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
POPULATION HEALTH RESEARCH INSTITUTE DE LA UNIVERSIDAD MC MASTER DE CANADA,0 个研究点目标入组 211 人开始时间: 2011年5月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 211
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 45 至 90（—）
- 性别
- All
入选标准
- •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:
- •o History of coronary artery disease
- •o History of peripheral vascular disease
- •o History of stroke
- •o Undergoing major vascular surgery
- •o Any 3 of the following 9 criteria:
- •undergoing major surgery (i.e. intraperitoneal, intrathoracic, retroperitoneal 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
排除标准
- •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. Thienopyridine (e.g., clopidogrel, ticlopidine, prasugrel) or ticagrelor within 72 hours prior to surgery; or intent to restart a thienopyridine or ticagrelor during the first 7 days post-op; or currently taking an alpha-2 agonist, alpha methyldopa, monoamine oxidase inhibitors or reserpine;
- •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
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