EUCTR2005-002161-36-IT进行中（未招募）不适用
RANDOMIZED COMPARISON OF A TWO-MONTH REGIMEN OF IRBESARTAN VERSUS ENALAPRIL ON CARDIOVASCULAR MARKERS IN PATIENTS WITH ACUTE CORONARY SYNDROME WITHOUT ST SEGMENT ELEVATION. - ARCHIPELAGO
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients male or female 1 Age or to 18 years old 2 Patients hospitalized with ischemic symptoms last episode within the last 48 hours before randomization and at least one of the following characteristics of acute coronary syndrome without persistent ST segment elevation - ECG ST or T changes ST depression or transient elevation of at least 1mm or T wave changes in at least 2 leads - Positive troponin according to local threshold 3 Signed written informed consent obtained
- •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
排除标准
- •RELATED TO THE PATIENT. 1 Women of child bearing potential WCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study WOCBP using a prohibited contraceptive method not applicable 2 Women pregnant or breast feeding 3 Women with a positive pregnancy test on enrolment or prior to study drug administration 4 Subjects with inability to follow protocol procedures according to the investigation. 5 Patients with dementia. 6 Patients unable to come back at all follow-up visits. RELATED TO THE DISEASE / CONCOMITAMT DISEASES. 7 Persistent ST segment elevation at ECG. 8 Systolic blood pressure 100mmHg. 9 Bilateral stenosis of renal artery. 10 Creatinine clearance or to 30 ml/mn based on admission serum creatinine value and the Cockcroft formula 11 Congestive hearth failure with symptoms consistent with New York Hearth Association NYHA class III or IV. 12 Aortic or mitral valve stenosis 13 Hypertrophic cardiomyopathy 14 Connective tissue disease with vascular involvement 15 Angioplasty or surgery or trauma within the last 3 months. 16 Coronarography/angioplasty planned to be performed or performed before baseline sampling. 17 Febrile disease or to 38 C , known concomitant viral or bacterial infection, chronic auto immune disease, chronic inflammatory disease, known cancer in evolution. 18 Hyperkalemia serum potassium 5.5 mmol/l. 19 Life expentancy less than one year. RELATED TO STUDY DRUG/CONCOMITANT THERAPY. 20 Sensitivity or intolerance to ARBs olmesartan, candesartan, irbesartan, eprosartan, losartan, telmisartan, valsartan and/or any other ARB currently or previously in development . 21 Sensitivity or intolerance to ACE-I benazepril, captopril, enalapril, lisinopril, trendolapril, ramipril, quinapril, and/or any other ACE-I currently or previously in development. 22 Chronic steroid or non steroidal anti inflammatory drugs NSAIDs use. Aspirin is permitted. 23 Treatment with allopurinol or procainamide 24 Concomintant use of potassium sparing diuretics e.g. spironolactone, triamterene or amiloride , potassium preparations, or salt substitutes containing potassium 25 Treatment with lithium. 26 Immunosupressive medication. 27 Administration of any other investigational drug in the last 30 days before enrollment and during the course of the study. OTHER EXCLUSION CRITERIA. 28 Prisoners or subjects who are compulsorily detained involuntarily incarcerated for treatment or either a psychiatric or physical e.g., infectious disease illness must not be enrolled into this study.
研究者
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