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Clinical Trials List

Protocol NumberCLCZ696G2301
NCT Number(ClinicalTrials.gov Identfier)NCT02924727

2016-11-01 - 2021-04-10

Phase III

Not yet recruiting2

Terminated7

ICD-10I21.3

ST elevation (STEMI) myocardial infarction of unspecified site

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

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

    Novartis Pharmaceuticals

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Ping-Han Lo Division of Cardiovascular Diseases
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 蔣俊彥 Division of Cardiovascular Diseases
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Ming-Shien Wen Division of Cardiovascular Diseases
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yen-Wen Wu Division of Cardiovascular Diseases
Far Eastern Memorial Hospital

Co-Principal Investigator

  • 廖本智 Division of Cardiovascular Diseases
  • 張藝耀 Division of Cardiovascular Diseases
  • 林恆旭 Division of Cardiovascular Diseases
  • 莊文博 Division of Cardiovascular Diseases
  • 曾炳憲 Division of Cardiovascular Diseases
  • 許榮城 Division of Cardiovascular Diseases
  • 邱昱偉 Division of Cardiovascular Diseases
  • 柯欣榮 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 曹玄明 Division of General Internal Medicine
National Yang-Ming University Hospital

Co-Principal Investigator

  • 黃嵩豪 Division of General Internal Medicine
  • 廖照峰 Division of General Internal Medicine
  • 陳偉華 Division of General Internal Medicine
  • 陳思穎 Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 蘇正煌 無
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Shih-Hsien Sung 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Hsien Li Kao Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Condition/Disease

acute myocardial infarction

Objectives

Primary Objective: To demonstrate that LCZ696 is superior to ramipril in delaying the time to first occurrence of the composite endpoint of CV death, HF hospitalization or outpatient HF* in patients with LV systolic dysfunction and/or pulmonary congestion following an AMI. (*The outpatient HF endpoint event is defined as an adjudicated event of clinical development of symptomatic HF (either urgent/unscheduled or non-urgent) in the outpatient setting with symptoms and signs requiring initiation/intensification of intravenous or qualifying oral HF treatment.)

Test Drug

LCZ696

Active Ingredient

Sacubitril/Valsartan as Sacubitril Valsartan sodium salt complex

Dosage Form

film-coated tablet

Dosage

50mg、100mg、200mg

Endpoints

Primary endpoint(s):
The primary efficacy endpoint is defined as the time to the first confirmed occurrence of CV
death, heart failure hospitalization or outpatient heart failure

Inclution Criteria

Key inclusion criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Male or female patients ≥ 20 years of age.
3. 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.
4. Evidence of LV systolic dysfunction and/or pulmonary congestion requiring intravenous treatment
associated with the index MI event defined as:
 Left ventricular ejection fraction (LVEF) ≤ 40% assessed locally by echocardiography, magnetic
resonance imaging, cardiac CT, radionuclide or contrast ventriculography after index MI
presentation** and prior to randomization.
 Pulmonary congestion requiring intravenous treatment during the index hospitalization supported
by clinical assessment (worst Killip class, II or above) 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.
5. 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 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 < 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 defined as:
 Systolic blood pressure (SBP) ≥ 100 mmHg at randomization for patients who received ACE
inhibitor/angiotensin receptor blocker (ARB) during the last 24 hours prior to randomization
(ACE inhibitor/ARB Yes patients)
 SBP ≥ 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.

Exclusion Criteria

Key exclusion criteria:
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 inhibitors
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
21. Any surgical or medical condition which might significantly alter the absorption, distribution,
metabolism, or extraction of study drug at investigators’ discretion
22. History or evidence of drug or alcohol abuse within the last 12 months
23. 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
24. 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
25. 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

The Estimated Number of Participants

  • Taiwan

    91 participants

  • Global

    5670 participants

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