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 INFARCTIO

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 28 人开始时间: 2017年2月16日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1. Written informed consent.
•2. At least18 years of age.
•3. Diagnosis of spontaneous AMI with randomization to occur between 12 hours and 7 days after index event presentation.
•4. Evidence of LV systolic dysfunction and/or pulmonary congestion requiring intravenous treatment associated with the index MI event.
•5. At least one of the 8 risk factors: Age ≥ 70 years, eGFR <60 mL/min/1.73 m2, Type I or II diabetes mellitus, history of prior MI supported by ECG changes and/or elevation of
•cardiac enzymes, atrial fibrillation, 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
•6. Hemodynamically stable.

•1 History of chronic HF prior to randomization.
•2 Cardiogenic shock within 24h prior to randomization.
•3 Persistent clinical HF at the time of randomization.
•4 Coronary artery bypass graft.
•5. Clinically significant right ventricular MI as index MI.
•6. Symptomatic hypotension.
•7 History of angioedema.
•8. Stroke or transient ischemic attack 1 month prior to randomization.
•9. Known or suspected bilateral renal artery stenosis.
•10. Clinically significant obstructive cardiomyopathy.
•11. Open-heart surgery 1 month prior to randomization or planned cardiac surgery within the 3 months after randomization.
•12. eGFR < 30 ml/min/1.73 m2 at V1.
•13. Serum potassium > 5.2 mmol /L at V1.
•14. Known hepatic impairment or history of cirrhosis.
•15 Previous use of LCZ696.
•16 Other investigational drugs 30 days prior to V1.
•17 Hypersensitivity to the study drugs.
•18 Intolerance to study drugs.
•19 Taking medications prohibited by the protocol.
•20 History of malignancy of any organ system.
•21 Medical condition at investigators’ discretion.
•22 Drug or alcohol abuse.
•23 Patients considered unsuitable for the study.
•24 Pregnant or nursing.
•25 Women of child-bearing potential unless using highly effective methods of contraception.

发起方

OVARTIS BIOSCIENSES PERU S.A.,