Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI
Launched by NOVARTIS PHARMACEUTICALS · Oct 4, 2016
Trial Information
Current as of May 28, 2025
Completed
Keywords
ClinConnect 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.
Gender
ALL
Eligibility criteria
- 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 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
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Zwolle, , Netherlands
Durham, North Carolina, United States
Medford, Oregon, United States
Brasschaat, , Belgium
Lisboa, , Portugal
Bern, , Switzerland
Northridge, California, United States
Duluth, Minnesota, United States
Robbinsdale, Minnesota, United States
Omaha, Nebraska, United States
Hershey, Pennsylvania, United States
Danville, Virginia, United States
Herston, Queensland, Australia
Bogota, , Colombia
Vejle, , Denmark
Grenoble Cedex 9, , France
Amersfoort, , Netherlands
Madrid, , Spain
Leuven, , Belgium
Yvoir, , Belgium
Berlin, , Germany
Pavia, Pv, Italy
Roma, Rm, Italy
Napoli, , Italy
Warszawa, , Poland
Southfield, Michigan, United States
Valhalla, New York, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Sainte Foy, Quebec, Canada
Paris, , France
Essen, , Germany
Kiel, , Germany
Taipei, , Taiwan
Taoyuan, , Taiwan
Graz, , Austria
Belfast, , United Kingdom
Geelong, Victoria, Australia
Salzburg, , Austria
Aalst, , Belgium
Turnhout, , Belgium
Viborg, , Denmark
Freiburg, , Germany
Veldhoven, , Netherlands
Malaga, Andalucia, Spain
La Coruna, Galicia, Spain
Bournemouth, , United Kingdom
Chapel Hill, North Carolina, United States
Toronto, Ontario, Canada
Baltimore, Maryland, United States
Hackensack, New Jersey, United States
Herlev, , Denmark
Dresden, , Germany
Frankfurt, , Germany
Pavia, , Italy
Uppsala, , Sweden
Birmingham, , United Kingdom
Leeds, , United Kingdom
New York, New York, United States
Charlotte, North Carolina, United States
Hobart, Tasmania, Australia
Petach Tikva, , Israel
Groningen, , Netherlands
Leeuwarden, , Netherlands
Sibiu, , Romania
Singapore, , Singapore
St Gallen, , Switzerland
Chiang Mai, , Thailand
San Francisco, California, United States
Esslingen, , Germany
Rotterdam, , Netherlands
Detroit, Michigan, United States
Lebanon, New Hampshire, United States
Newcastle Upon Tyne, , United Kingdom
Bellevue, Washington, United States
Linz, , Austria
Pessac Cedex, , France
Athens, Gr, Greece
Barcelona, , Spain
Iowa City, Iowa, United States
Rapid City, South Dakota, United States
Izmir, , Turkey
Orange, California, United States
Sao Paulo, Sp, Brazil
Koeln, , Germany
Bergamo, Bg, Italy
Valencia, Comunidad Valenciana, Spain
Richmond, Indiana, United States
Lansing, Michigan, United States
Saginaw, Michigan, United States
Saint Cloud, Minnesota, United States
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
Springfield, Missouri, United States
Grand Forks, North Dakota, United States
Canton, Ohio, United States
Genk, , Belgium
Varna, , Bulgaria
Praha 10, , Czechia
Bron, , France
Wuerzburg, , Germany
Gouda, , Netherlands
Springfield, Massachusetts, United States
Hattiesburg, Mississippi, United States
Huntsville, Alabama, United States
Cumming, Georgia, United States
Slidell, Louisiana, United States
Dallas, Texas, United States
Caba, Buenos Aires, Argentina
Corrientes, , Argentina
Nanjing, Jiangsu, China
Hvidovre, , Denmark
Tampere, , Finland
Corbeil Essonnes, , France
Paris Cedex 18, , France
Bremen, , Germany
Neuwied, , Germany
Debrecen, , Hungary
Catanzaro, Cz, Italy
Almelo, , Netherlands
Breda, , Netherlands
Venlo, , Netherlands
Cercado De Lima, Lima, Peru
Bratislava, Slovak Republic, Slovakia
Lugano, , Switzerland
Kocaeli, , Turkey
Saint Petersburg, , Russian Federation
Nitra, Slovak Republic, Slovakia
Fortaleza, Ce, Brazil
Saint Petersburg, , Russian Federation
Rosario, Santa Fe, Argentina
Brescia, Bs, Italy
Trieste, Ts, Italy
Lynchburg, Virginia, United States
Rockville, Maryland, United States
Munster, Indiana, United States
Norwich, , United Kingdom
Bangor, Maine, United States
Barranquilla, , Colombia
Alkmaar, , Netherlands
Chemside, Queensland, Australia
Hennigsdorf, , Germany
Badalona, Catalunya, Spain
Lee's Summit, Missouri, United States
Innsbruck, Tyrol, Austria
Haifa, , Israel
La Plata, Buenos Aires, Argentina
Jesus Maria, Lima, Peru
Craigavon, Northern Ireland, United Kingdom
Pleven, , Bulgaria
Shijiazhuang, Hebei, China
Shengyang, Liaoning, China
Ashkelon, , Israel
Coimbra, , Portugal
Caceres, Extremadura, Spain
Taichung, , Taiwan
Jacksonville Beach, Florida, United States
Lincoln, Nebraska, United States
Tucuman, San Miguel De Tucuman, Argentina
San Miguel De Tucuman, Tucuman, Argentina
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Tianjin, Tianjin, China
Coburg, , Germany
Witten, , Germany
Madurai, Tamil Nadu, India
Hyderabad, Telangana, India
Milano, Mi, Italy
Rimini, Rn, Italy
Zutphen, , Netherlands
Saratov, , Russian Federation
Worcester, , South Africa
Villamartin, Cadiz, Spain
Istanbul, , Turkey
Sivas, , Turkey
Glasgow, , United Kingdom
Covington, Louisiana, United States
Petoskey, Michigan, United States
Toulouse Cedex, , France
Ludwigshafen, , Germany
Neuss, , Germany
Pecs, Baranya, Hungary
Guangzhou, Guangdong, China
Seoul, , Korea, Republic Of
Greenville, South Carolina, United States
Ede, , Netherlands
Baia Mare, , Romania
A Coruna, Galicia, Spain
Sylmar, California, United States
Greifswald, , Germany
Langen, , Germany
Budapest, , Hungary
Grosseto, Gr, Italy
Craiova, , Romania
S. Petersburg, , Russian Federation
Coeur D'alene, Idaho, United States
Plovdiv, , Bulgaria
Khon Kaen, Tha, Thailand
Gilbert, Arizona, United States
Tel Aviv, , Israel
Sevilla, Andalucia, Spain
Larissa, Gr, Greece
Alexandria, Louisiana, United States
Formosa, , Argentina
San Luis, , Argentina
Victoria, British Columbia, Canada
Beijing, Beijing, China
Bucaramanga, Santander, Colombia
Bad Krozingen, , Germany
Riesa, , Germany
Gurgaon, Haryana, India
Mumbai, Maharashtra, India
Nashik, Maharashtra, India
Bikaner, Rajasthan, India
Queretaro, , Mexico
Quezon City, Manila, Philippines
Covilha, , Portugal
Kemerovo, , Russian Federation
Krasnodar, , Russian Federation
Moscow, , Russian Federation
N.Novgorod, , Russian Federation
Nizhnii Novgorod, , Russian Federation
El Palmar, Murcia, Spain
Basingstoke, Hampshire, United Kingdom
Worcester, , United Kingdom
Jyvaskyla, , Finland
Szeged, , Hungary
Stavanger, , Norway
Guadalajara, Jalisco, Mexico
Edegem, Antwerpen, Belgium
Bedford Park, South Australia, Australia
Lubin, , Poland
Ciudad De Salta, Provincia De Salta, Argentina
St Poelten, , Austria
Praha, , Czechia
Augsburg, , Germany
Erfurt, , Germany
Alexandroupolis, Evros, Greece
Szekesfehervar, , Hungary
Sefad, , Israel
Trabzon, , Turkey
Middlesbrough, , United Kingdom
Hammond, Louisiana, United States
North Kansas City, Missouri, United States
Glostrup, , Denmark
Blagoevgrad, , Bulgaria
Falls Church, Virginia, United States
Terrebonne, Quebec, Canada
Leicester, , United Kingdom
Eskisehir, Meselik, Turkey
Leverkusen, , Germany
Wuhan, Hubei, China
Leon, Castilla Y Leon, Spain
Birmingham, Alabama, United States
Carmichael, California, United States
Hollywood, Florida, United States
Thomasville, Georgia, United States
Baton Rouge, Louisiana, United States
Kalamazoo, Michigan, United States
Knoxville, Tennessee, United States
Webster, Texas, United States
Uberlandia, Minas Gerais, Brazil
Porto Alegre, Rs, Brazil
Campinas, Sp, Brazil
Sao Jose Do Rio Preto, Sp, Brazil
Harbin, Heilongjiang, China
Xian, Shanxi, China
Barranquilla, , Colombia
Cakovec, , Croatia
Brno Bohunice, , Czechia
Zalaegerszeg, Zala, Hungary
Kochi, Kerala, India
Secunderabad, Telangana, India
Gwangju, , Korea, Republic Of
Sneek, The Netherlands, Netherlands
Bellavista, Lima, Peru
Pitesti, Arges, Romania
Bucuresti, District 4, Romania
Oradea, Jud Bihor, Romania
Iasi, Jud Iasi, Romania
Targu Mures, Mures, Romania
Braila, Rom, Romania
Timisoara, Timis, Romania
Sestroretsk, , Russian Federation
Tomsk, , Russian Federation
Yekaterinburg, , Russian Federation
Vasteras, , Sweden
Tainan, , Taiwan
Yilan, , Taiwan
Edmonton, Alberta, Canada
Boise, Idaho, United States
New Delhi, Delhi, India
Bangkok, Tha, Thailand
Trois Rivieres, Quebec, Canada
Bakersfield, California, United States
Gabrovo, , Bulgaria
Changsha, Hunan, China
Guetersloh, , Germany
Brandon, Florida, United States
Murdoch, Western Australia, Australia
Manila, Metro Manila, Philippines
Villingen Schwenningen, , Germany
Campina Grande Do Sul, , Brazil
Braga, , Portugal
Presov, , Slovakia
Haifa, , Israel
Bologna, Bo, Italy
Karamsad, Gujrat, India
Lanzhou, Gansu, China
Ahmedabad, Gujarat, India
Shanghai, Shanghai, China
Wien, , Austria
Chang Chun, Jilin, China
Muncie, Indiana, United States
Jackson, Mississippi, United States
Cincinnati, Ohio, United States
Santa Fe, , Argentina
Braunau, , Austria
Curitiba, Parana, Brazil
Kladno, Czech Republic, Czechia
Liberec, Czech Republic, Czechia
Koeln Nippes, , Germany
Ruesselsheim, , Germany
Lower Galilee, , Israel
Barnaul, , Russian Federation
Marseille Cedex 8, , France
Flushing, New York, United States
Svendborg, , Denmark
Cheongju Si, Chungcheongbuk Do, Korea, Republic Of
Wonju, Gangwon Do, Korea, Republic Of
Torreon, Coahulia, Mexico
New Taipei, , Taiwan
Clydebank, West Dumbartonshire, United Kingdom
Tilburg, , Netherlands
Cali, Valle Del Cauca, Colombia
Jinshan, Shanghai, China
Wenzhou, Zhejiang, China
Vadodara, Gujarat, India
Almada, , Portugal
Mersin, , Turkey
Moenchengladbach, , Germany
Stadtlohn, , Germany
Vechta, , Germany
Lublin, , Poland
Bucharest, , Romania
Goiania, Go, Brazil
Stockholm, Se, Sweden
Ruse, , Bulgaria
El Palmar (Murcia), , Spain
Leiderdorp, , Netherlands
Leiria, , Portugal
Aalborg, , Denmark
Zlin, Czech Republic, Czechia
Bialystok, , Poland
Plzen Bory, , Czechia
Dehradun, Uttarakhand, India
Cordoba, , Argentina
San Luis Potosi, , Mexico
Helsingborg, , Sweden
Gralum, , Norway
Carnaxide, Lisboa, Portugal
Chambray Les Tours, , France
Badalona, Barcelona, Spain
Zagreb, Hrv, Croatia
Oslo, , Norway
Sofia, Bgr, Bulgaria
Los Alamitos, California, United States
Lima, , Peru
Iloilo City, Iloilo, Philippines
Ocala, Florida, United States
Johns Creek, Georgia, United States
Erie, Pennsylvania, United States
York, Pennsylvania, United States
Columbia, South Carolina, United States
Manassas, Virginia, United States
Buenos Aires, Caba, Argentina
Belo Horizonte, Mg, Brazil
Blumenau, Sc, Brazil
Sao Jose, , Brazil
Burgas, Bgr, Bulgaria
Kardzhali, , Bulgaria
Pernik, , Bulgaria
Xicheng, Beijing, China
Lanzhou, Gansu, China
Yanji, Jilin, China
Jinan, Shandong, China
Medellin, Antioquia, Colombia
Prague 4, , Czechia
Kaupio, , Finland
Nagpur, Maharashtra, India
Pune, Maharashtra, India
Cona, Fe, Italy
Sanremo, Im, Italy
Grosseto, , Italy
Culiacan Sinaloa, Distrito Federal, Mexico
Ciudad De Mexico, , Mexico
Amsterdam, , Netherlands
Beverwijk, , Netherlands
Heemstede, , Netherlands
Uden, , Netherlands
Faro, , Portugal
Guimaraes, , Portugal
Vila Real, , Portugal
Cluj Napoca, Jud Cluj, Romania
Suceava, Rom, Romania
Murmansk, , Russian Federation
Rostov On Don, , Russian Federation
Sochy, , Russian Federation
St Petersburg, , Russian Federation
Banska Bystrica, Svk, Slovakia
Kosice, , Slovakia
Pinelands, Cape Town, South Africa
Cape Town, Western Cape, South Africa
George, Western Cape, South Africa
Goethenburg, , Sweden
Malmo, , Sweden
Luzern 16, , Switzerland
Ankara Cankaya, , Turkey
Kucukcekmece/Istanbul, , Turkey
Lincoln, Lincolnshire, United Kingdom
Meselik, Eskisehir, Turkey
Bucaramanga, Santander, Colombia
Goethenburg, , Sweden
Bogota, , Colombia
Yanji, Jilin, China
Kucukcekmece Istanbul, , Turkey
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials