EUCTR2004-001150-88-ES进行中（未招募）不适用
Comparison between zofenopril and ramipril in combination with ASA on the extent of cardiovascular risk in patients with systolic left ventricular dysfunction after acute myocardial infarction (SMILE IV trial) - MEN/03/ZOF-CHF/001Protocol Final version dated: 23 Dec 2003Amendment No. 1 Final version dated: 01 Jul 2004Amendment No. 2 Final version dated: 26 Apr 2005 - SMILE IV
Menarini International Operation Luxembourg -SA0 个研究点目标入组 896 人开始时间: 2005年7月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 896
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
- •At day 1: a) Written informed consent of the patient; b) Male and female aged 18-85 years; c) Patient suffering from ST-segment elevation acute myocardial infarction, during the 24 hours before inclusion in the study, with clinical (i.e. Killip class > 1, and combination with at least one of the following criteria: 31 heart sound or pulmonary congestion on chest X-ray) or echocardiographic (i.e. LVEF < 45%) evidence of systolic LV dysfunction.
- •At day 5: Patient suffering from ST-segment elevation acute myocardial infarction, during the 24 hours before inclusion in the study, with clinical (i.e. Killip class > 1, and combination with at least one of the following criteria: 31 heart sound or pulmonary congestion on chest X-ray) or echocardiographic (i.e. LVEF < 45%) evidence of systolic LV dysfunction.
- •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
- •At day 1: a) Ipersensibility to ACEI or ASA; b) Severe hypotension (SBP < 90 mmHg) defined as systolic blood pressure < 90 mmHg, measured twice, with an interval of 1 hour between the two measurements; c) Renal failure with serum creatinine > 2.1 mg/dL (186 µmol/L); d) Angioneurotic oedema; e)Severe liver failure (AST and/or ALT 3 times the upper normal limit); f) Bilateral stenosis of renal artery or unilateral stenosis in patients with one kidney; g)Mitral or aortic stenosis; h) thrombocytopenia, leucopenia, agranulocytosis; i)Hemorrhagic diseases, disease that may give bleeding (i.e gastric ulcer); j) Occurrence of gastric ulcer in the past 5 years; k) Acute stroke; l) LES and/or systemic sclerodermia; m) Concomitant chronic anticoagulant treatment (i.e. heparin, acenocumarol, anisindione, dicumarol, warfarin, etc.); n) Rescue PTCA; o) Any other reason according with Investigator's judgement that controindicate the participation of the patient to the study;
- •p) If female, not pregnant or lactating. Documentation of a negative pregnancy test for women of childbearing potential is required prior to enrolment. Women of childbearing potential must use a contraceptive method.
- •At day 5: a) Ipersensibility to ACEI, or ASA; b) Severe hypotension (SBP < 90 mmHg) defined as systolic blood pressure < 90 mmHg, measured twice, with an interval of 1 hour between the two measurements; c) Renal failure with serum creatinine > 2.1 mg/dL (186 µmol/L); d) Angioneurotic oedema; e)Severe liver failure (AST and/or ALT 3 times the upper normal limit); f) Bilateral stenosis of renal artery or unilateral stenosis in patients with only one kidney; g) Mitral or aortic stenosis; h) Thrombocytopenia, leucopenia, agranulocytosis; i)Hemorrhagic diseases, disease that may give bleeding (i.e. gastric ulcer); j) Occurrence of gastric ulcer in the past 5 years; k)Acute stroke; l) LES and/or systemic sclerodermia; m) Concomitant chronic anticoagulant treatment (i.e. heparin, acenocumarol, anisindione, dicumarol, warfarin, etc.); n) Rescue PTCA; o) Secondary PTCA planned in the next months due to cardiac conditions; p) Any other reason according with Investigator's judgement that controindicate the participation of the patient to the study; q) Pregnancy, breastfeeding and women with childbearing potential not using effective contraception.
研究者
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