A multi-center, randomized, double-blind, active-controlled, parallel-groupPhase 3 study to evaluate the efficacy and safety of LCZ696 compared toramipril on morbidity and mortality in high risk patients following an acutemyocardial infarction - PARADISE-MI

ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 3 期
状态: 进行中（未招募）
发起方

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

入选标准

•Written informed consent must be obtained before any assessment is performed.
•Male or female patients greater than equal to 18 years of age.
•At least one of the following 8 risk factors:
•Age greater than equal to 70 years
•eGFR less than 60 mL per min per1.73 m2 based on MDRD formula at screening visit
•Type I or II diabetes mellitus
•Documented history of prior MI supported by ECG changes and or elevation of
•cardiac enzymes consistent with MI diagnosis.
•Atrial fibrillation as noted by ECG, associated with index MI
•LVEF less than 30percent 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.
•Hemodynamically stable defined as:
•SBP greater than equal to 100 mmHg at randomization for patients who received ACE inhibitor or ARB during the last 24 hours prior to randomization (ACE inhibitor/ARB Yes patients)
•SBP greater than equal to 110 mmHg at randomization for patients who did not receive ACE inhibitor/ARB during the last 24 hours prior to randomization (ACE inhibitor/ARB No patients)
•No intravenous treatment with diuretics, vasodilators, vasopressors and/or inotropes
•during the last 24 hours prior to randomization.
•Evidence of LV systolic dysfunction and/or pulmonary congestion requiring intravenous
•treatment associated with the index MI event defined as:
•LVEF less than equal to 40percent assessed locally by echocardiography, magnetic resonance imaging, cardiac CT, radionuclide or contrast ventriculography after index MI presentation and prior to randomization.
•(These examinations may be performed as part of patient standard-of-care. In case multiple LVEF measurements have been performed during index event, the last one performed prior to randomization should be considered as the qualifying measurement), and/or
•- Pulmonary congestion requiring intravenous treatment during the index hospitalization
•supported by clinical assessment (worst Killip class, II or above; see Appendix 3 for
•Killip class definition) or radiological findings. Radiological evidence of pulmonary
•congestion is defined as pulmonary venous congestion with interstitial or alveolar
•edema and must be supported by at least one chest X-ray or CT scan.

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
•randomization or planned cardiac surgery within the 3 months after
•randomization
•12. eGFR < 30 ml/min/1.73 m2 as measured by the Modification of Diet in
•Renal Disease (MDRD) formula at screening
•13. Serum potassium > 5.2 mmol /L at screening
•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 varices
•15. Previous use of LCZ696 or EntrestoTM
•16. Use of other investigational drugs within 30 days prior to screening
•17. History of hypersensitivity to the study drugs or drugs of similar
•chemical classes
•18. Known intolerance or contraindications to study drugs or drugs of
•similar chemical classes including ACE inhibitors, ARB or NEP
•19. Patients taking medications prohibited by the protocol that cannot be
•discontinued for the duration of the study
•20. 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.

研究者

发起方

ovartis Healthcare Pvt Ltd

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