A multi-center, randomized, double-blind, active-controlled, parallelgroup Phase 3 study to evaluate the efficacy and safety of LCZ696 compared to ramipril on morbidity and mortality in high risk<br>patients following an acute myocardial infarction - CLCZ696G2301 (PARADISE-MI)

ovartis0 个研究点目标入组 250 人开始时间: 待定最近更新: 2024年2月28日

试验速览

阶段: 3 期
状态: 已完成
发起方: ovartis
入组人数: 250

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 64（—）

入选标准

•- Male or female patients * 18 years of age.
•- Diagnosis of spontaneous AMI based on the universal myocardial infarction
•(MI) definition with randomization to occur between 12 hours and 7 days after
•index event presentation.
•- 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
•- At least one of the following 8 risk factors:
•* Age * 70 years
•* eGFR <60 mL/min/1.73 m2 based on Modification of Diet in Renal Disease (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
•* STEMI without reperfusion therapy within the first 24 hours after presentation
•- 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 intravenous treatment with diuretics, vasodilators, vasopressors and/or
•inotropes during the last 24 hours prior to randomization
•Other protocol-defined inclusion criteria may apply.

排除标准

•- Known history of chronic HF prior to randomization
•- Cardiogenic shock within the last 24 hours prior to randomization
•- Persistent clinical HF at the time of randomization
•- Coronary artery bypass graft (CABG) performed or planned for index MI
•- Clinically significant right ventricular MI as index MI
•- Symptomatic hypotension at screening or randomization
•- Patients with a known history of angioedema
•- Stroke or transient ischemic attack within one month prior to randomization
•- Known or suspected bilateral renal artery stenosis
•- Clinically significant obstructive cardiomyopathy
•- Open-heart surgery performed within one month prior to randomization or
•planned cardiac surgery within the 3 months after randomization
•- eGFR < 30 ml/min/1.73 m2 as measured by the Modification of Diet in Renal
•Disease (MDRD) formula at screening
•- Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at
•randomization
•- 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
•- Previous use of LCZ696 or Entresto
•- Use of other investigational drugs within 30 days prior to screening
•- History of hypersensitivity to the study drugs or drugs of similar chemical
•- Known intolerance or contraindications to study drugs or drugs of similar
•chemical classes including ACE inhibitors, ARB or NEP inhibitors
•- Patients taking medications prohibited by the protocol that cannot be
•discontinued for the duration of the study
•- 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 1 year
•- Any surgical or medical condition which might significantly alter the
•absorption, distribution, metabolism, or extraction of study drug at
•investigators* discretion
•- History or evidence of drug or alcohol abuse within the last 12 months
•- Patients considered unsuitable for the study, including patients with
•psychiatric, behavioral or cognitive disorders, sufficient to interfere with
•the patient*s ability to understand and comply with the protocol instructions
•or follow-up procedures
•- Pregnant or nursing (lactating) women, where pregnancy is defined as the
•state of a female after conception and until the termination of gestation,
•confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
•- Women of child-bearing potential, defined as all women physiologically
•capable of becoming pregnant, unless they are using highly effective methods of
•contraception during dosing of investigational drug
•Other protocol-defined exclusion criteria may apply.

研究者

发起方

ovartis

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