Combined angioplasty and pharmacological intervention versus thrombolysis alone in acute myocardial infarction (CAPITAL AMI Study)

niversity of Ottawa Heart Institute (Canada)0 个研究点目标入组 170 人开始时间: 2005年9月5日最近更新: 2015年1月13日

试验速览

暂无简介。

•1. Ischemic chest discomfort of =30 minutes duration
•2. Aged 18 years and older, either sex
•3. Onset of Chest Pain =6 hours prior to entry into the study and one of the following high risk criteria:
•3.1. Anterior AMI with ST-segment elevation =2 mm in each of at least contiguous precordial leads (V1-V6)
•3.2. Extensive nonanterior AMI on a standard 12 lead electrocardiogram (ECG) defined as:
•3.2.1. Eight or more leads with =0.1 mV ST elevation or depression, or both; ST segment elevation of >1 mm (0.1 mV) must be present in two or more contiguous electrocardiographic leads
•3.2.2. Sum of ST-segment elevation >20 mm measured 60 msec after the J-point
•4. Killip 3 and either ST segment elevation of >1 mm (0.1 mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead ECG) or left bundle branch block not known to be old
•5. Systolic blood pressure <100 mmHg and either ST segment elevation of >1 mm (0.1mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead ECG) or left bundle branch block not known to be old

•1. Low risk AMI defined as having the absence of high risk features defined above
•2. Acute bleeding
•3. History of stroke or central nervous system (CNS) damage
•4. Major surgery or trauma within the past 3 months
•5. Uncontrolled hypertension (SBP =200 mmHg and/or DBP =120 mmHg despite treatment)
•6. Prolonged (>10 min) cardiopulmonary resuscitation
•7. Inadequate vascular access 8. Previous coronary artery bypass graft (CABG)
•9. PTCA within the last 6 months
•10. Abciximab (ReoPro TM) or other GP IIb/IIIa antagonists within the preceding 7 days
•11. Coagulation disorder (i.e. international normalized ratio (INR) >2.0, platelets <100,000/mm^3, or hematocrit <30%
•12. Current warfarin treatment
•13. Within 6 hours randomization, either:
•a. Standard unfractionated heparin (heparin sodium) =5000 IU
•b. A subcutaneous therapeutic dose of any low molecular weight heparin
•14. Intolerance to aspirin
•15. Other medical condition that is likely to result in death within 12 months
•16. Participation in a study with another investigational device or drug <4 weeks
•17. Pregnancy
•18. Known severe renal impairment (creatinine >300 µmol/l
•19. Sustained hypotension defined as SBP <90 mmHg or the need for intravenous (IV) inotropes and/or intraaortic balloon counter pulsation to support the blood pressure
•20. Known severe contrast (dye) allergy
•21. Inability to provide informed consent

发起方

niversity of Ottawa Heart Institute (Canada)