EUCTR2005-002161-36-DE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 = 18 years old
- •2)Patient 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 who are 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)Patient with dementia
- •6)Patients unable to come back at all follow-up visits
- •Related to the disease/concomitant diseases
- •7)Persistent ST segment elevation at ECG
- •8)Systolic blood pressure < 100 mmHg
- •9)Bilateral stenosis of renal artery
- •10)Creatinine clairance < or = 30 ml/mn (based on admission serum creatinine value and the Cockcroft formula)
- •11)Congestive heart failure with symptoms consistent with New York Heart 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 (= 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 expectancy 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,
- •22)Chronic steroid or non-steroidal anti inflammatory drugs (NSAIDs) use. Aspirin is permitted.
- •23)Treatment with allopurinol or procaïnamide
- •24)Concomitant use of potassium sparing diuretics (eg. 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 enrolment and during the course of the study.
- •28)Treatment with ARB or ACE inhibitor within the last 3 days.
- •Other exclusion criterion
- •29)Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
研究者
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