EUCTR2016-002154-20-BG进行中（未招募）1 期
A multi-center, randomized, double-blind, active-controlled, parallel-group Phase 3 study to evaluate the efficacy and safety of LCZ696 compared to ramipril on morbidity and mortality in high risk patients following an acute myocardial infarction - PARADISE-MI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5,650
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
- •1. Male or female patients = 18 years of age.
- •2. Diagnosis of spontaneous AMI based on the universal MI definition with randomization to occur between 12 hours and 7 days after index event presentation.
- •3. Evidence of LV systolic dysfunction and/or pulmonary congestion requiring intravenous treatment associated with the index MI event defined as:
- •LVEF =40% after index MI presentation and prior to randomization and/or
- •Pulmonary congestion requiring intravenous treatment during the index hospitalization
- •4. At least one of the following 8 risk factors:
- •Age = 70 years
- •eGFR <60 mL/min/1.73 m2 based on MDRD formula at screening visit
- •Type I or II diabetes mellitus
- •Documented history of prior MI
- •Atrial fibrillation as noted by ECG, associated with index MI
- •LVEF <30% associated with index MI
- •Worst Killip class III or IV associated with index MI requiring intravenous treatment
- •STEMI without reperfusion therapy within the first 24 hours after presentation
- •5. Hemodynamically stable defined as:
- •SBP = 100 mmHg at randomization for patients who received ACEi/ARB during the last 24 hours prior to randomization
- •SBP = 110 mmHg at randomization for patients who did not receive ACEi/ARB during the last 24 hours prior to randomization
- •No IV treatment with diuretics, vasodilators, vasopressors and/or inotropes during the 24 hours prior to randomization
- •Other protocol-defined inclusion criteria may apply.
- •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 2797
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2853
排除标准
- •1. Known history of chronic HF prior to randomization
- •2. Cardiogenic shock within the last 24 hours prior to randomization
- •3. Persistent clinical HF at the time of randomization
- •4. Coronary artery bypass graft (CABG) performed or planned for index MI
- •5. Clinically significant right ventricular MI as index MI
- •6. Symptomatic hypotension at screening or randomization
- •7. Patients with a known history of angioedema
- •8. Stroke or transient ischemic attack within one month prior to randomization
- •9. Known or suspected bilateral renal artery stenosis
- •10. Clinically significant obstructive cardiomyopathy
- •11. Open-heart surgery performed within one month prior to rand or planned cardiac surgery w/in the 3 months prior to rand
- •12. eGFR < 30 ml/min/1.73 m2 as measured by MDRD at screening
- •13. Serum potassium > 5.2 mmol /L at (or equivalent plasma potassium value) randomization
- •14. Known hepatic impairment (as evidenced by total bilirubin > 3.0 mg/dL or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as esophageal varices
- •15. Previous use of LCZ696 or Entresto
- •16. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin) within the past 3 years with a life expectancy of less than 1year.
- •17. History of hypersensitivity to the study drugs or drugs of similar chemical classes or known intolerance or contraindications to study drugs or drugs of similar chemical classes including ACE inhibitors, ARB or NEP inhibitors
- •18. Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception
- •Other protocol-defined exclusion criteria may apply.
研究者
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