The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02924727




Registration number
NCT02924727
Ethics application status
Date submitted
4/10/2016
Date registered
5/10/2016
Date last updated
15/05/2020

Titles & IDs
Public title
Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI
Scientific title
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 AMI
Secondary ID [1] 0 0
2016-002154-20
Secondary ID [2] 0 0
CLCZ696G2301
Universal Trial Number (UTN)
Trial acronym
PARADISE-MI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LCZ696 (sacubitril/valsartan)
Treatment: Drugs - Ramipril
Treatment: Drugs - Placebo of LCZ696
Treatment: Drugs - Placebo of ramipril
Treatment: Drugs - Valsartan
Treatment: Drugs - Placebo of valsartan

Experimental: LCZ696 (sacubitril/valsartan) - Following randomization, patients will receive LCZ696 in titrated doses from level 1 up to level 3 (50, 100 and 200 mg twice daily).
Patients will be required to take a total of two pills, (one tablet from the LCZ696 pack and one capsule from ramipril matching placebo pack) twice a day for the duration of the study.
Patients randomized to LCZ who were previously treated with ACE inhibitors receiving the last dose of that agent during the last 36 hours prior to randomization will receive a valsartan bridge for one day. These patients will receive two doses of valsartan for 1 day in a blinded manner prior to beginning double-blind LCZ696 treatment.

Active Comparator: Ramipril - Following randomization, patients will receive the Ramipril in titrated doses from level 1 up to level 3 (1.25, 2.5 and 5 mg twice daily).
Patients will be required to take a total of two pills, (one capsule from the ramipril pack and one tablet from LCZ696 matching placebo pack) twice a day for the duration of the study.
Patients randomized to ramipril who were previously treated with ACE inhibitors receiving the last dose of that agent during the last 36 hours prior to randomization will immediately start on double-blind ramipril; however, to maintain double blind/double dummy of the valsartan bridge, these patients will receive two doses of matching valsartan placebo for 1 day in a blinded manner prior to beginning double-blind LCZ696 placebo.


Treatment: Drugs: LCZ696 (sacubitril/valsartan)
LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively

Treatment: Drugs: Ramipril
Ramipril 1.25 mg, 2.5 mg, and 5 mg oral capsules

Treatment: Drugs: Placebo of LCZ696
Matching placebo of LCZ696 tablets

Treatment: Drugs: Placebo of ramipril
Matching placebo of ramipril capsule

Treatment: Drugs: Valsartan
Valsartan (VAL489) 40 mg and 80 mg tablets, two doses for 1 day to patients who were previously treated with ACE inhibitors receiving the last dose of that agent during the last 36 hours prior to randomization

Treatment: Drugs: Placebo of valsartan
matching placebo of valsartan for one day to patients who will be randomized to received ramipril

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to the first occurrence of a confirmed composite endpoint - A confirmed composite endpoint includes cardiovascular (CV) death, heart failure (HF) hospitalization, or outpatient heart failure
Timepoint [1] 0 0
Time from randomization to first occurrence (up to approximately 43 months)
Secondary outcome [1] 0 0
Time to the first occurrence of a confirmed composite of CV death or HF hospitalization - A confirmed composite endpoint for this outcome measure includes cardiovascular death or heart failure hospitalization.
Timepoint [1] 0 0
Time from randomization to first occurrence (up to approximately 43 months)
Secondary outcome [2] 0 0
Time to the first occurrence of a confirmed composite of HF hospitalization or outpatient HF - A confirmed composite endpoint includes first occurrence of heart failure hospitalization or outpatient heart failure
Timepoint [2] 0 0
Time from randomization to first occurrence (approximately up to 43 months)
Secondary outcome [3] 0 0
Time to the first occurrence of a confirmed composite of CV death, non-fatal spontaneous myocardial infarction or non-fatal stroke - A confirmed composite endpoint for this outcome measure includes cardiovascular death, non-fatal spontaneous myocardial infarction or non-fatal stroke
Timepoint [3] 0 0
Time from randomization to first occurrence (approximately up to 43 months)
Secondary outcome [4] 0 0
Total number of recurrent confirmed composite endpoints - A confirmed composite endpoint includes cardiovascular death, heart failure hospitalization, non-fatal spontaneous MI hospitalization, and non-fatal stroke hospitalization
Timepoint [4] 0 0
Time from randomization to end of study (approximately up to 43 months)
Secondary outcome [5] 0 0
Time to all-cause mortality - All-cause mortality defined as death related to CV and non-CV events.
Timepoint [5] 0 0
Time from randomization to death (approximately up to 43 months)

Eligibility
Key inclusion criteria
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. (*patients with
spontaneous MI event determined to be secondary to another medical condition such as
anemia, hypotension, or arrhythmia OR thought to be caused by coronary vasospasm with
document normal coronary arteries are not eligible; patients with clinical
presentation thought to be related to Takotsubo cardiomyopathy are also not eligible)

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 with diuretics,
vasodilators, vasopressors and/or inotropes, during the index hospitalization

4. At least one of the following 8 risk factors:

- Age = 70 years

- eGFR <60 mL/min/1.73 m^2 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

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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 w/in the 3 months prior to randomization

12. eGFR < 30 ml/min/1.73 m^2 as measured by MDRD at screening

13. Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at 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

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Chemside
Recruitment hospital [2] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [3] 0 0
Novartis Investigative Site - Bedford Park
Recruitment hospital [4] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [5] 0 0
Novartis Investigative Site - Geelong
Recruitment hospital [6] 0 0
Novartis Investigative Site - Murdoch
Recruitment postcode(s) [1] 0 0
4032 - Chemside
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5041 - Bedford Park
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maine
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Mississippi
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
Nebraska
Country [18] 0 0
United States of America
State/province [18] 0 0
New Hampshire
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
North Dakota
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oregon
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
South Dakota
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
Argentina
State/province [32] 0 0
Buenos Aires
Country [33] 0 0
Argentina
State/province [33] 0 0
Caba
Country [34] 0 0
Argentina
State/province [34] 0 0
Provincia De Salta
Country [35] 0 0
Argentina
State/province [35] 0 0
San Miguel De Tucuman
Country [36] 0 0
Argentina
State/province [36] 0 0
Santa Fe
Country [37] 0 0
Argentina
State/province [37] 0 0
Tucuman
Country [38] 0 0
Argentina
State/province [38] 0 0
Cordoba
Country [39] 0 0
Argentina
State/province [39] 0 0
Corrientes
Country [40] 0 0
Argentina
State/province [40] 0 0
Formosa
Country [41] 0 0
Argentina
State/province [41] 0 0
San Luis
Country [42] 0 0
Austria
State/province [42] 0 0
Tyrol
Country [43] 0 0
Austria
State/province [43] 0 0
Braunau
Country [44] 0 0
Austria
State/province [44] 0 0
Graz
Country [45] 0 0
Austria
State/province [45] 0 0
Linz
Country [46] 0 0
Austria
State/province [46] 0 0
Salzburg
Country [47] 0 0
Austria
State/province [47] 0 0
St Poelten
Country [48] 0 0
Austria
State/province [48] 0 0
Wien
Country [49] 0 0
Belgium
State/province [49] 0 0
Aalst
Country [50] 0 0
Belgium
State/province [50] 0 0
Brasschaat
Country [51] 0 0
Belgium
State/province [51] 0 0
Edegem
Country [52] 0 0
Belgium
State/province [52] 0 0
Genk
Country [53] 0 0
Belgium
State/province [53] 0 0
Leuven
Country [54] 0 0
Belgium
State/province [54] 0 0
Turnhout
Country [55] 0 0
Belgium
State/province [55] 0 0
Yvoir
Country [56] 0 0
Brazil
State/province [56] 0 0
CE
Country [57] 0 0
Brazil
State/province [57] 0 0
GO
Country [58] 0 0
Brazil
State/province [58] 0 0
MG
Country [59] 0 0
Brazil
State/province [59] 0 0
Minas Gerais
Country [60] 0 0
Brazil
State/province [60] 0 0
Parana
Country [61] 0 0
Brazil
State/province [61] 0 0
RS
Country [62] 0 0
Brazil
State/province [62] 0 0
SC
Country [63] 0 0
Brazil
State/province [63] 0 0
SP
Country [64] 0 0
Brazil
State/province [64] 0 0
Campina Grande do Sul
Country [65] 0 0
Brazil
State/province [65] 0 0
Sao Jose
Country [66] 0 0
Bulgaria
State/province [66] 0 0
BGR
Country [67] 0 0
Bulgaria
State/province [67] 0 0
Blagoevgrad
Country [68] 0 0
Bulgaria
State/province [68] 0 0
Burgas
Country [69] 0 0
Bulgaria
State/province [69] 0 0
Gabrovo
Country [70] 0 0
Bulgaria
State/province [70] 0 0
Kardzhali
Country [71] 0 0
Bulgaria
State/province [71] 0 0
Pernik
Country [72] 0 0
Bulgaria
State/province [72] 0 0
Pleven
Country [73] 0 0
Bulgaria
State/province [73] 0 0
Plovdiv
Country [74] 0 0
Bulgaria
State/province [74] 0 0
Ruse
Country [75] 0 0
Bulgaria
State/province [75] 0 0
Sofia
Country [76] 0 0
Bulgaria
State/province [76] 0 0
Varna
Country [77] 0 0
Canada
State/province [77] 0 0
Alberta
Country [78] 0 0
Canada
State/province [78] 0 0
British Columbia
Country [79] 0 0
Canada
State/province [79] 0 0
Ontario
Country [80] 0 0
Canada
State/province [80] 0 0
Quebec
Country [81] 0 0
China
State/province [81] 0 0
Beijing
Country [82] 0 0
China
State/province [82] 0 0
Gansu
Country [83] 0 0
China
State/province [83] 0 0
Guangdong
Country [84] 0 0
China
State/province [84] 0 0
Hebei
Country [85] 0 0
China
State/province [85] 0 0
Heilongjiang
Country [86] 0 0
China
State/province [86] 0 0
Hubei
Country [87] 0 0
China
State/province [87] 0 0
Hunan
Country [88] 0 0
China
State/province [88] 0 0
Jiangsu
Country [89] 0 0
China
State/province [89] 0 0
Jilin
Country [90] 0 0
China
State/province [90] 0 0
Liaoning
Country [91] 0 0
China
State/province [91] 0 0
Shandong
Country [92] 0 0
China
State/province [92] 0 0
Shanghai
Country [93] 0 0
China
State/province [93] 0 0
Shanxi
Country [94] 0 0
China
State/province [94] 0 0
Tianjin
Country [95] 0 0
China
State/province [95] 0 0
Zhejiang
Country [96] 0 0
China
State/province [96] 0 0
Wuhan
Country [97] 0 0
Colombia
State/province [97] 0 0
Antioquia
Country [98] 0 0
Colombia
State/province [98] 0 0
Santander
Country [99] 0 0
Colombia
State/province [99] 0 0
Valle Del Cauca
Country [100] 0 0
Colombia
State/province [100] 0 0
Barranquilla
Country [101] 0 0
Colombia
State/province [101] 0 0
Bogota
Country [102] 0 0
Croatia
State/province [102] 0 0
HRV
Country [103] 0 0
Croatia
State/province [103] 0 0
Cakovec
Country [104] 0 0
Croatia
State/province [104] 0 0
Zagreb
Country [105] 0 0
Czechia
State/province [105] 0 0
Czech Republic
Country [106] 0 0
Czechia
State/province [106] 0 0
Brno Bohunice
Country [107] 0 0
Czechia
State/province [107] 0 0
Plzen-Bory
Country [108] 0 0
Czechia
State/province [108] 0 0
Prague 4
Country [109] 0 0
Czechia
State/province [109] 0 0
Praha 10
Country [110] 0 0
Czechia
State/province [110] 0 0
Praha
Country [111] 0 0
Denmark
State/province [111] 0 0
Aalborg
Country [112] 0 0
Denmark
State/province [112] 0 0
Glostrup
Country [113] 0 0
Denmark
State/province [113] 0 0
Herlev
Country [114] 0 0
Denmark
State/province [114] 0 0
Hvidovre
Country [115] 0 0
Denmark
State/province [115] 0 0
Svendborg
Country [116] 0 0
Denmark
State/province [116] 0 0
Vejle
Country [117] 0 0
Denmark
State/province [117] 0 0
Viborg
Country [118] 0 0
Finland
State/province [118] 0 0
Jyvaskyla
Country [119] 0 0
Finland
State/province [119] 0 0
Kaupio
Country [120] 0 0
Finland
State/province [120] 0 0
Tampere
Country [121] 0 0
France
State/province [121] 0 0
Bron
Country [122] 0 0
France
State/province [122] 0 0
Chambray les Tours
Country [123] 0 0
France
State/province [123] 0 0
Corbeil Essonnes
Country [124] 0 0
France
State/province [124] 0 0
Grenoble Cedex 9
Country [125] 0 0
France
State/province [125] 0 0
Marseille Cedex 8
Country [126] 0 0
France
State/province [126] 0 0
Paris cedex 18
Country [127] 0 0
France
State/province [127] 0 0
Paris
Country [128] 0 0
France
State/province [128] 0 0
Pessac Cedex
Country [129] 0 0
France
State/province [129] 0 0
Toulouse Cedex
Country [130] 0 0
Germany
State/province [130] 0 0
Augsburg
Country [131] 0 0
Germany
State/province [131] 0 0
Bad Krozingen
Country [132] 0 0
Germany
State/province [132] 0 0
Berlin
Country [133] 0 0
Germany
State/province [133] 0 0
Bremen
Country [134] 0 0
Germany
State/province [134] 0 0
Coburg
Country [135] 0 0
Germany
State/province [135] 0 0
Dresden
Country [136] 0 0
Germany
State/province [136] 0 0
Erfurt
Country [137] 0 0
Germany
State/province [137] 0 0
Essen
Country [138] 0 0
Germany
State/province [138] 0 0
Esslingen
Country [139] 0 0
Germany
State/province [139] 0 0
Frankfurt
Country [140] 0 0
Germany
State/province [140] 0 0
Freiburg
Country [141] 0 0
Germany
State/province [141] 0 0
Greifswald
Country [142] 0 0
Germany
State/province [142] 0 0
Guetersloh
Country [143] 0 0
Germany
State/province [143] 0 0
Hennigsdorf
Country [144] 0 0
Germany
State/province [144] 0 0
Kiel
Country [145] 0 0
Germany
State/province [145] 0 0
Koeln-Nippes
Country [146] 0 0
Germany
State/province [146] 0 0
Koeln
Country [147] 0 0
Germany
State/province [147] 0 0
Langen
Country [148] 0 0
Germany
State/province [148] 0 0
Leverkusen
Country [149] 0 0
Germany
State/province [149] 0 0
Ludwigshafen
Country [150] 0 0
Germany
State/province [150] 0 0
Moenchengladbach
Country [151] 0 0
Germany
State/province [151] 0 0
Neuss
Country [152] 0 0
Germany
State/province [152] 0 0
Neuwied
Country [153] 0 0
Germany
State/province [153] 0 0
Riesa
Country [154] 0 0
Germany
State/province [154] 0 0
Ruesselsheim
Country [155] 0 0
Germany
State/province [155] 0 0
Stadtlohn
Country [156] 0 0
Germany
State/province [156] 0 0
Vechta
Country [157] 0 0
Germany
State/province [157] 0 0
Villingen-Schwenningen
Country [158] 0 0
Germany
State/province [158] 0 0
Witten
Country [159] 0 0
Germany
State/province [159] 0 0
Wuerzburg
Country [160] 0 0
Greece
State/province [160] 0 0
Evros
Country [161] 0 0
Greece
State/province [161] 0 0
GR
Country [162] 0 0
Greece
State/province [162] 0 0
Athens
Country [163] 0 0
Hungary
State/province [163] 0 0
Baranya
Country [164] 0 0
Hungary
State/province [164] 0 0
Zala
Country [165] 0 0
Hungary
State/province [165] 0 0
Budapest
Country [166] 0 0
Hungary
State/province [166] 0 0
Debrecen
Country [167] 0 0
Hungary
State/province [167] 0 0
Szeged
Country [168] 0 0
Hungary
State/province [168] 0 0
Szekesfehervar
Country [169] 0 0
India
State/province [169] 0 0
Delhi
Country [170] 0 0
India
State/province [170] 0 0
Gujarat
Country [171] 0 0
India
State/province [171] 0 0
Gujrat
Country [172] 0 0
India
State/province [172] 0 0
Haryana
Country [173] 0 0
India
State/province [173] 0 0
Kerala
Country [174] 0 0
India
State/province [174] 0 0
Maharashtra
Country [175] 0 0
India
State/province [175] 0 0
Rajasthan
Country [176] 0 0
India
State/province [176] 0 0
Tamil NADU
Country [177] 0 0
India
State/province [177] 0 0
Telangana
Country [178] 0 0
India
State/province [178] 0 0
Uttarakhand
Country [179] 0 0
Israel
State/province [179] 0 0
Ashkelon
Country [180] 0 0
Israel
State/province [180] 0 0
Haifa
Country [181] 0 0
Israel
State/province [181] 0 0
Lower Galilee
Country [182] 0 0
Israel
State/province [182] 0 0
Petach Tikva
Country [183] 0 0
Israel
State/province [183] 0 0
Sefad
Country [184] 0 0
Israel
State/province [184] 0 0
Tel Aviv
Country [185] 0 0
Italy
State/province [185] 0 0
BG
Country [186] 0 0
Italy
State/province [186] 0 0
BO
Country [187] 0 0
Italy
State/province [187] 0 0
BS
Country [188] 0 0
Italy
State/province [188] 0 0
CZ
Country [189] 0 0
Italy
State/province [189] 0 0
FE
Country [190] 0 0
Italy
State/province [190] 0 0
IM
Country [191] 0 0
Italy
State/province [191] 0 0
MI
Country [192] 0 0
Italy
State/province [192] 0 0
RM
Country [193] 0 0
Italy
State/province [193] 0 0
RN
Country [194] 0 0
Italy
State/province [194] 0 0
TS
Country [195] 0 0
Italy
State/province [195] 0 0
Grosseto
Country [196] 0 0
Italy
State/province [196] 0 0
Napoli
Country [197] 0 0
Italy
State/province [197] 0 0
Pavia
Country [198] 0 0
Korea, Republic of
State/province [198] 0 0
Chungcheongbuk Do
Country [199] 0 0
Korea, Republic of
State/province [199] 0 0
Gangwon-do
Country [200] 0 0
Korea, Republic of
State/province [200] 0 0
Gwangju
Country [201] 0 0
Korea, Republic of
State/province [201] 0 0
Seoul
Country [202] 0 0
Mexico
State/province [202] 0 0
Coahulia
Country [203] 0 0
Mexico
State/province [203] 0 0
Distrito Federal
Country [204] 0 0
Mexico
State/province [204] 0 0
Jalisco
Country [205] 0 0
Mexico
State/province [205] 0 0
Ciudad de Mexico
Country [206] 0 0
Mexico
State/province [206] 0 0
Queretaro
Country [207] 0 0
Mexico
State/province [207] 0 0
San Luis Potosi
Country [208] 0 0
Netherlands
State/province [208] 0 0
The Netherlands
Country [209] 0 0
Netherlands
State/province [209] 0 0
Alkmaar
Country [210] 0 0
Netherlands
State/province [210] 0 0
Almelo
Country [211] 0 0
Netherlands
State/province [211] 0 0
Amersfoort
Country [212] 0 0
Netherlands
State/province [212] 0 0
Amsterdam
Country [213] 0 0
Netherlands
State/province [213] 0 0
Beverwijk
Country [214] 0 0
Netherlands
State/province [214] 0 0
Breda
Country [215] 0 0
Netherlands
State/province [215] 0 0
Ede
Country [216] 0 0
Netherlands
State/province [216] 0 0
Gouda
Country [217] 0 0
Netherlands
State/province [217] 0 0
Groningen
Country [218] 0 0
Netherlands
State/province [218] 0 0
Heemstede
Country [219] 0 0
Netherlands
State/province [219] 0 0
Leeuwarden
Country [220] 0 0
Netherlands
State/province [220] 0 0
Leiderdorp
Country [221] 0 0
Netherlands
State/province [221] 0 0
Rotterdam
Country [222] 0 0
Netherlands
State/province [222] 0 0
Tilburg
Country [223] 0 0
Netherlands
State/province [223] 0 0
Uden
Country [224] 0 0
Netherlands
State/province [224] 0 0
Veldhoven
Country [225] 0 0
Netherlands
State/province [225] 0 0
Venlo
Country [226] 0 0
Netherlands
State/province [226] 0 0
Zutphen
Country [227] 0 0
Netherlands
State/province [227] 0 0
Zwolle
Country [228] 0 0
Norway
State/province [228] 0 0
Gralum
Country [229] 0 0
Norway
State/province [229] 0 0
Oslo
Country [230] 0 0
Norway
State/province [230] 0 0
Stavanger
Country [231] 0 0
Peru
State/province [231] 0 0
Lima
Country [232] 0 0
Philippines
State/province [232] 0 0
Iloilo
Country [233] 0 0
Philippines
State/province [233] 0 0
Manila
Country [234] 0 0
Philippines
State/province [234] 0 0
Metro Manila
Country [235] 0 0
Poland
State/province [235] 0 0
Bialystok
Country [236] 0 0
Poland
State/province [236] 0 0
Lubin
Country [237] 0 0
Poland
State/province [237] 0 0
Lublin
Country [238] 0 0
Poland
State/province [238] 0 0
Warszawa
Country [239] 0 0
Portugal
State/province [239] 0 0
Lisboa
Country [240] 0 0
Portugal
State/province [240] 0 0
Almada
Country [241] 0 0
Portugal
State/province [241] 0 0
Braga
Country [242] 0 0
Portugal
State/province [242] 0 0
Coimbra
Country [243] 0 0
Portugal
State/province [243] 0 0
Covilha
Country [244] 0 0
Portugal
State/province [244] 0 0
Faro
Country [245] 0 0
Portugal
State/province [245] 0 0
Guimaraes
Country [246] 0 0
Portugal
State/province [246] 0 0
Leiria
Country [247] 0 0
Portugal
State/province [247] 0 0
Vila Real
Country [248] 0 0
Romania
State/province [248] 0 0
Arges
Country [249] 0 0
Romania
State/province [249] 0 0
District 4
Country [250] 0 0
Romania
State/province [250] 0 0
Jud Bihor
Country [251] 0 0
Romania
State/province [251] 0 0
Jud Cluj
Country [252] 0 0
Romania
State/province [252] 0 0
Jud Iasi
Country [253] 0 0
Romania
State/province [253] 0 0
Mures
Country [254] 0 0
Romania
State/province [254] 0 0
ROM
Country [255] 0 0
Romania
State/province [255] 0 0
Timis
Country [256] 0 0
Romania
State/province [256] 0 0
Baia Mare
Country [257] 0 0
Romania
State/province [257] 0 0
Bucharest
Country [258] 0 0
Romania
State/province [258] 0 0
Bucuresti
Country [259] 0 0
Romania
State/province [259] 0 0
Craiova
Country [260] 0 0
Romania
State/province [260] 0 0
Sibiu
Country [261] 0 0
Romania
State/province [261] 0 0
Timisoara
Country [262] 0 0
Russian Federation
State/province [262] 0 0
Barnaul
Country [263] 0 0
Russian Federation
State/province [263] 0 0
Kemerovo
Country [264] 0 0
Russian Federation
State/province [264] 0 0
Krasnodar
Country [265] 0 0
Russian Federation
State/province [265] 0 0
Moscow
Country [266] 0 0
Russian Federation
State/province [266] 0 0
Murmansk
Country [267] 0 0
Russian Federation
State/province [267] 0 0
N.Novgorod
Country [268] 0 0
Russian Federation
State/province [268] 0 0
Nizhnii Novgorod
Country [269] 0 0
Russian Federation
State/province [269] 0 0
Rostov on Don
Country [270] 0 0
Russian Federation
State/province [270] 0 0
S.-Petersburg
Country [271] 0 0
Russian Federation
State/province [271] 0 0
Saint Petersburg
Country [272] 0 0
Russian Federation
State/province [272] 0 0
Saint-Petersburg
Country [273] 0 0
Russian Federation
State/province [273] 0 0
Saratov
Country [274] 0 0
Russian Federation
State/province [274] 0 0
Sestroretsk
Country [275] 0 0
Russian Federation
State/province [275] 0 0
Sochy
Country [276] 0 0
Russian Federation
State/province [276] 0 0
St Petersburg
Country [277] 0 0
Russian Federation
State/province [277] 0 0
Tomsk
Country [278] 0 0
Russian Federation
State/province [278] 0 0
Yekaterinburg
Country [279] 0 0
Singapore
State/province [279] 0 0
Singapore
Country [280] 0 0
Slovakia
State/province [280] 0 0
Slovak Republic
Country [281] 0 0
Slovakia
State/province [281] 0 0
SVK
Country [282] 0 0
Slovakia
State/province [282] 0 0
Bratislava
Country [283] 0 0
Slovakia
State/province [283] 0 0
Kosice
Country [284] 0 0
Slovakia
State/province [284] 0 0
Presov
Country [285] 0 0
South Africa
State/province [285] 0 0
Cape Town
Country [286] 0 0
South Africa
State/province [286] 0 0
Western Cape
Country [287] 0 0
South Africa
State/province [287] 0 0
Worcester
Country [288] 0 0
Spain
State/province [288] 0 0
Andalucia
Country [289] 0 0
Spain
State/province [289] 0 0
Barcelona
Country [290] 0 0
Spain
State/province [290] 0 0
Cadiz
Country [291] 0 0
Spain
State/province [291] 0 0
Castilla Y Leon
Country [292] 0 0
Spain
State/province [292] 0 0
Comunidad Valenciana
Country [293] 0 0
Spain
State/province [293] 0 0
Extremadura
Country [294] 0 0
Spain
State/province [294] 0 0
Galicia
Country [295] 0 0
Spain
State/province [295] 0 0
El Palmar (Murcia)
Country [296] 0 0
Spain
State/province [296] 0 0
Madrid
Country [297] 0 0
Spain
State/province [297] 0 0
Valencia
Country [298] 0 0
Sweden
State/province [298] 0 0
SE
Country [299] 0 0
Sweden
State/province [299] 0 0
Goethenburg
Country [300] 0 0
Sweden
State/province [300] 0 0
Helsingborg
Country [301] 0 0
Sweden
State/province [301] 0 0
Malmo
Country [302] 0 0
Sweden
State/province [302] 0 0
Stockholm
Country [303] 0 0
Sweden
State/province [303] 0 0
Uppsala
Country [304] 0 0
Sweden
State/province [304] 0 0
Vasteras
Country [305] 0 0
Switzerland
State/province [305] 0 0
Bern
Country [306] 0 0
Switzerland
State/province [306] 0 0
Lugano
Country [307] 0 0
Switzerland
State/province [307] 0 0
Luzern 16
Country [308] 0 0
Switzerland
State/province [308] 0 0
St Gallen
Country [309] 0 0
Taiwan
State/province [309] 0 0
New Taipei
Country [310] 0 0
Taiwan
State/province [310] 0 0
Taichung
Country [311] 0 0
Taiwan
State/province [311] 0 0
Tainan
Country [312] 0 0
Taiwan
State/province [312] 0 0
Taipei
Country [313] 0 0
Taiwan
State/province [313] 0 0
Taoyuan
Country [314] 0 0
Taiwan
State/province [314] 0 0
Yilan
Country [315] 0 0
Thailand
State/province [315] 0 0
THA
Country [316] 0 0
Thailand
State/province [316] 0 0
Bangkok
Country [317] 0 0
Thailand
State/province [317] 0 0
Chiang Mai
Country [318] 0 0
Turkey
State/province [318] 0 0
Meselik
Country [319] 0 0
Turkey
State/province [319] 0 0
Ankara-Cankaya
Country [320] 0 0
Turkey
State/province [320] 0 0
Istanbul
Country [321] 0 0
Turkey
State/province [321] 0 0
Izmir
Country [322] 0 0
Turkey
State/province [322] 0 0
Kocaeli
Country [323] 0 0
Turkey
State/province [323] 0 0
Kucukcekmece/Istanbul
Country [324] 0 0
Turkey
State/province [324] 0 0
Mersin
Country [325] 0 0
Turkey
State/province [325] 0 0
Sivas
Country [326] 0 0
Turkey
State/province [326] 0 0
Trabzon
Country [327] 0 0
United Kingdom
State/province [327] 0 0
Hampshire
Country [328] 0 0
United Kingdom
State/province [328] 0 0
Lincolnshire
Country [329] 0 0
United Kingdom
State/province [329] 0 0
Northern Ireland
Country [330] 0 0
United Kingdom
State/province [330] 0 0
West Dumbartonshire
Country [331] 0 0
United Kingdom
State/province [331] 0 0
Belfast
Country [332] 0 0
United Kingdom
State/province [332] 0 0
Birmingham
Country [333] 0 0
United Kingdom
State/province [333] 0 0
Bournemouth
Country [334] 0 0
United Kingdom
State/province [334] 0 0
Glasgow
Country [335] 0 0
United Kingdom
State/province [335] 0 0
Leeds
Country [336] 0 0
United Kingdom
State/province [336] 0 0
Leicester
Country [337] 0 0
United Kingdom
State/province [337] 0 0
Middlesborough
Country [338] 0 0
United Kingdom
State/province [338] 0 0
Newcastle upon Tyne
Country [339] 0 0
United Kingdom
State/province [339] 0 0
Norwich
Country [340] 0 0
United Kingdom
State/province [340] 0 0
Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a
target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg
twice daily, in addition to conventional post-AMI treatment, in reducing the occurrence of
composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event
analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary
congestion, with no known prior history of chronic HF..
Trial website
https://clinicaltrials.gov/show/NCT02924727
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications