AzTrials
AzTrials

Acute Myocardial InfarctionPhase 3PARADISE-MINCT02924727

Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI

A Phase 3 study testing LCZ696 (sacubitril/valsartan), Ramipril and Valsartan in people with Acute Myocardial Infarction, run by Novartis Pharmaceuticals at 486 sites in 41 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
LCZ696 (sacubitril/valsartan), Ramipril and Valsartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,669 participants
Where
486 sitesin 41 countries
Study dates
9 Dec 2016to 26 Feb 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients ≥ 18 years of age.
  • 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)
  • 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
  • At least one of the following 8 risk factors:
Show all 18Show fewer
  • 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
  • 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

Who cannot join

  • Known history of chronic HF prior to randomization
  • Cardiogenic shock within the last 24 hours prior to randomization
  • Persistent clinical HF at the time of randomization
  • Coronary artery bypass graft (CABG) performed or planned for index MI
  • Clinically significant right ventricular MI as index MI
  • Symptomatic hypotension at screening or randomization
Show all 18Show fewer
  • Patients with a known history of angioedema
  • Stroke or transient ischemic attack within one month prior to randomization
  • Known or suspected bilateral renal artery stenosis
  • Clinically significant obstructive cardiomyopathy
  • Open-heart surgery performed within one month prior to randomization or planned cardiac surgery w/in the 3 months prior to randomization
  • eGFR < 30 ml/min/1.73 m^2 as measured by MDRD at screening
  • Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at randomization
  • 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
  • Previous use of LCZ696
  • 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.
  • 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
  • Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception

Trial locations and contacts

486 sites in 41 countries.

486 sites in 41 countries

United States81 sites

  • Novartis Investigative Site

    Alexandria, Louisiana, 71301

  • Novartis Investigative Site

    Bakersfield, California, 93301

  • Novartis Investigative Site

    Baltimore, Maryland, 21201

  • Novartis Investigative Site

    Baltimore, Maryland, 21218

  • Novartis Investigative Site

    Bangor, Maine, 04401

  • Novartis Investigative Site

    Baton Rouge, Louisiana, 70808

  • Novartis Investigative Site

    Bellevue, Washington, 98004

  • Novartis Investigative Site

    Birmingham, Alabama, 35243

  • Novartis Investigative Site

    Birmingham, Alabama, 35294-2041

  • Novartis Investigative Site

    Boise, Idaho, 83702

  • Novartis Investigative Site

    Brandon, Florida, 33511

  • Novartis Investigative Site

    Canton, Ohio, 44710

  • Novartis Investigative Site

    Carmichael, California, 95608

  • Novartis Investigative Site

    Chapel Hill, North Carolina, 27599

  • Novartis Investigative Site

    Charleston, South Carolina, 29403

  • Novartis Investigative Site

    Charlotte, North Carolina, 28204

  • Novartis Investigative Site

    Cincinnati, Ohio, 45220

  • Novartis Investigative Site

    Coeur d'Alene, Idaho, 83814

  • Novartis Investigative Site

    Columbia, South Carolina, 29203

  • Novartis Investigative Site

    Covington, Louisiana, 70433

  • Novartis Investigative Site

    Cumming, Georgia, 30041

  • Novartis Investigative Site

    Dallas, Texas, 75226

  • Novartis Investigative Site

    Danville, Virginia, 24541

  • Novartis Investigative Site

    Detroit, Michigan, 48201

  • Novartis Investigative Site

    Duluth, Minnesota, 55805

  • Novartis Investigative Site

    Durham, North Carolina, 27710

  • Novartis Investigative Site

    Erie, Pennsylvania, 16550

  • Novartis Investigative Site

    Falls Church, Virginia, 22042

  • Novartis Investigative Site

    Flushing, New York, 11355

  • Novartis Investigative Site

    Gilbert, Arizona, 85297

  • Novartis Investigative Site

    Grand Forks, North Dakota, 58201

  • Novartis Investigative Site

    Greenville, South Carolina, 29607

  • Novartis Investigative Site

    Hackensack, New Jersey, 07601

  • Novartis Investigative Site

    Hammond, Louisiana, 70403

  • Novartis Investigative Site

    Hattiesburg, Mississippi, 39401

  • Novartis Investigative Site

    Hershey, Pennsylvania, 17033

  • Novartis Investigative Site

    Hollywood, Florida, 33312

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Huntsville, Alabama, 35801

  • Novartis Investigative Site

    Iowa City, Iowa, 52242

  • Novartis Investigative Site

    Jackson, Mississippi, 39216

  • Novartis Investigative Site

    Jacksonville Beach, Florida, 32050

  • Novartis Investigative Site

    Johns Creek, Georgia, 30024

  • Novartis Investigative Site

    Kalamazoo, Michigan, 49008

  • Novartis Investigative Site

    Knoxville, Tennessee, 37917

  • Novartis Investigative Site

    Lansing, Michigan, 48912

  • Novartis Investigative Site

    Lebanon, New Hampshire, 03756

  • Novartis Investigative Site

    Lee's Summit, Missouri, 64064

  • Novartis Investigative Site

    Lincoln, Nebraska, 68506

  • Novartis Investigative Site

    Lincoln, Nebraska, 68526

  • Novartis Investigative Site

    Los Alamitos, California, 90720

  • Novartis Investigative Site

    Lynchburg, Virginia, 24501

  • Novartis Investigative Site

    Manassas, Virginia, 20109

  • Novartis Investigative Site

    Medford, Oregon, 97504

  • Novartis Investigative Site

    Muncie, Indiana, 47303-3400

  • Novartis Investigative Site

    Munster, Indiana, 46321

  • Novartis Investigative Site

    Nashville, Tennessee, 37212

  • Novartis Investigative Site

    New York, New York, 10016

  • Novartis Investigative Site

    New York, New York, 10029

  • Novartis Investigative Site

    North Kansas City, Missouri, 64116

  • Novartis Investigative Site

    Northridge, California, 91325

  • Novartis Investigative Site

    Ocala, Florida, 34480

  • Novartis Investigative Site

    Omaha, Nebraska, 68114

  • Novartis Investigative Site

    Orange, California, 92868

  • Novartis Investigative Site

    Petoskey, Michigan, 49770

  • Novartis Investigative Site

    Rapid City, South Dakota, 57701

  • Novartis Investigative Site

    Richmond, Indiana, 47374

  • Novartis Investigative Site

    Robbinsdale, Minnesota, 55422

  • Novartis Investigative Site

    Rockville, Maryland, 20850

  • Novartis Investigative Site

    Saginaw, Michigan, 48601

  • Novartis Investigative Site

    Saint Cloud, Minnesota, 56303

  • Novartis Investigative Site

    Saint Paul, Minnesota, 55101

  • Novartis Investigative Site

    San Francisco, California, 94143

  • Novartis Investigative Site

    Slidell, Louisiana, 70458

  • Novartis Investigative Site

    Southfield, Michigan, 48075

  • Novartis Investigative Site

    Springfield, Missouri, 65804

  • Novartis Investigative Site

    Sylmar, California, 91342

  • Novartis Investigative Site

    Thomasville, Georgia, 31792

  • Novartis Investigative Site

    Valhalla, New York, 10595

  • Novartis Investigative Site

    Webster, Texas, 77598

  • Novartis Investigative Site

    York, Pennsylvania, 17403

Other trials in United States

Germany31 sites

  • Novartis Investigative Site

    Augsburg, 86179

  • Novartis Investigative Site

    Bad Krozingen, 79189

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bremen, 28277

  • Novartis Investigative Site

    Coburg, 96450

  • Novartis Investigative Site

    Cologne, 50937

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Erfurt, 99089

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Esslingen am Neckar, 73730

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Frankfurt, 65929

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Greifswald, 17475

  • Novartis Investigative Site

    Gütersloh, 33332

  • Novartis Investigative Site

    Hennigsdorf, 16761

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Koeln-Nippes, 50733

  • Novartis Investigative Site

    Langen, 63225

  • Novartis Investigative Site

    Leverkusen, 51375

  • Novartis Investigative Site

    Ludwigshafen, 67063

  • Novartis Investigative Site

    Mönchengladbach, 41063

  • Novartis Investigative Site

    Neuss, 41464

  • Novartis Investigative Site

    Neuwied, 56564

  • Novartis Investigative Site

    Riesa, 01589

  • Novartis Investigative Site

    Rüsselsheim am Main, 65428

  • Novartis Investigative Site

    Stadtlohn, 48703

  • Novartis Investigative Site

    Vechta, 49377

  • Novartis Investigative Site

    Villingen-Schwenningen, 78052

  • Novartis Investigative Site

    Witten, 58455

  • Novartis Investigative Site

    Würzburg, 97080

Other trials in Germany

China26 sites

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100037

  • Novartis Investigative Site

    Beijing, 100029

  • Novartis Investigative Site

    Beijing, 100050

  • Novartis Investigative Site

    Beijing, 100191

  • Novartis Investigative Site

    Changchun, Jilin, 130021

  • Novartis Investigative Site

    Changsha, Hunan, 410011

  • Novartis Investigative Site

    Guangzhou, Guangdong, 51000

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150000

  • Novartis Investigative Site

    Jinan, Shandong, 250013

  • Novartis Investigative Site

    Jinshan, Shanghai Municipality, 201508

  • Novartis Investigative Site

    Lanzhou, Gansu, 730030

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210008

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029

  • Novartis Investigative Site

    Shanghai, Shanghai Municipality, 200120

  • Novartis Investigative Site

    Shanghai, 200080

  • Novartis Investigative Site

    Shengyang, Liaoning, 110016

  • Novartis Investigative Site

    Shijiazhuang, Hebei, 050000

  • Novartis Investigative Site

    Tianjin, Tianjin Municipality, 300121

  • Novartis Investigative Site

    Tianjin, 300052

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000

  • Novartis Investigative Site

    Wuhan, Hubei, 430060

  • Novartis Investigative Site

    Wuhan, 430022

  • Novartis Investigative Site

    Xian, Shanxi, 710061

  • Novartis Investigative Site

    Xicheng, Beijing Municipality, 100044

  • Novartis Investigative Site

    Yanji, Jilin, 133001

Other trials in China

Russia23 sites

  • Novartis Investigative Site

    Barnaul, 656038

  • Novartis Investigative Site

    Kemerovo, 650002

  • Novartis Investigative Site

    Krasnodar, 350086

  • Novartis Investigative Site

    Moscow, 115516

  • Novartis Investigative Site

    Moscow, 117292

  • Novartis Investigative Site

    Moscow, 121359

  • Novartis Investigative Site

    Moscow, 121552

  • Novartis Investigative Site

    Moscow, 127644

  • Novartis Investigative Site

    Murmansk, 183047

  • Novartis Investigative Site

    N.Novgorod, 603005

  • Novartis Investigative Site

    Nizhny Novgorod, 603126

  • Novartis Investigative Site

    Rostov-on-Don, 344068

  • Novartis Investigative Site

    S.-Petersburg, 192242

  • Novartis Investigative Site

    Saint Petersburg, 191014

  • Novartis Investigative Site

    Saint Petersburg, 191015

  • Novartis Investigative Site

    Saint Petersburg, 194044

  • Novartis Investigative Site

    Saint Petersburg, 194291

  • Novartis Investigative Site

    Saint Petersburg, 197341

  • Novartis Investigative Site

    Saratov, 410012

  • Novartis Investigative Site

    Sestroretsk, 197706

  • Novartis Investigative Site

    Sochy, 354057

  • Novartis Investigative Site

    Tomsk, 634012

  • Novartis Investigative Site

    Yekaterinburg, 620109

Other trials in Russia

Netherlands22 sites

  • Novartis Investigative Site

    Alkmaar, 1815 JD

  • Novartis Investigative Site

    Almelo, 7609 PP

  • Novartis Investigative Site

    Amersfoort, 3813 TZ

  • Novartis Investigative Site

    Amsterdam, 1091AC

  • Novartis Investigative Site

    Beverwijk, NL-1942 LE

  • Novartis Investigative Site

    Breda, 4818 CK

  • Novartis Investigative Site

    Ede, 6716 RP

  • Novartis Investigative Site

    Gouda, 2803 HH

  • Novartis Investigative Site

    Groningen, 9713 GZ

  • Novartis Investigative Site

    Heemstede, 2102 CW

  • Novartis Investigative Site

    Leeuwarden, 8934 AD

  • Novartis Investigative Site

    Leiderdorp, 2353 GA

  • Novartis Investigative Site

    Rotterdam, 3015 CE

  • Novartis Investigative Site

    Rotterdam, 3045 PM

  • Novartis Investigative Site

    Rotterdam, 3083 AN

  • Novartis Investigative Site

    Sneek, The Netherlands, 8601 ZR

  • Novartis Investigative Site

    Tilburg, 5042 AD

  • Novartis Investigative Site

    Uden, 5406 PT

  • Novartis Investigative Site

    Veldhoven, 5504 DB

  • Novartis Investigative Site

    Venlo, 5912 BL

  • Novartis Investigative Site

    Zutphen, 7207 AE

  • Novartis Investigative Site

    Zwolle, 8025 AB

Other trials in Netherlands

Argentina21 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires F.D., C1078AAI

  • Novartis Investigative Site

    Buenos Aires, B1602ABQ

  • Novartis Investigative Site

    Buenos Aires, B1846BMF

  • Novartis Investigative Site

    Buenos Aires, C1405CNF

  • Novartis Investigative Site

    Buenos Aires, C1428DCO

  • Novartis Investigative Site

    Buenos Aires, C1430EGF

  • Novartis Investigative Site

    Caba, Buenos Aires, C1280AEB

  • Novartis Investigative Site

    Córdoba, X5000

  • Novartis Investigative Site

    Córdoba, X5003DCP

  • Novartis Investigative Site

    Córdoba, X5004BAL

  • Novartis Investigative Site

    Córdoba, X5006CBI

  • Novartis Investigative Site

    Corrientes, W3400

  • Novartis Investigative Site

    Formosa, P3600

  • Novartis Investigative Site

    La Plata, Buenos Aires, B1900AWT

  • Novartis Investigative Site

    Rosario, Santa Fe Province, C2000DSR

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DSV

  • Novartis Investigative Site

    Salta, Salta Province, A4406BPF

  • Novartis Investigative Site

    San Luis, D5702JRS

  • Novartis Investigative Site

    San Miguel de Tucumán, San Miguel de Tucuman, T4000ICL

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000IFL

  • Novartis Investigative Site

    Santa Fe, S3000FUJ

Other trials in Argentina

Romania19 sites

  • Novartis Investigative Site

    Baia Mare, 430031

  • Novartis Investigative Site

    Brăila, ROM, 810249

  • Novartis Investigative Site

    Bucharest, District 4, 4204179

  • Novartis Investigative Site

    Bucharest, 011461

  • Novartis Investigative Site

    Bucharest, 014461

  • Novartis Investigative Site

    Bucharest, 022322

  • Novartis Investigative Site

    Bucharest, 041915

  • Novartis Investigative Site

    Bucharest, 050098

  • Novartis Investigative Site

    Cluj-Napoca, Jud Cluj, 400001

  • Novartis Investigative Site

    Craiova, 200642

  • Novartis Investigative Site

    Iași, Jud Iasi, 700732

  • Novartis Investigative Site

    Oradea, Jud Bihor, 410169

  • Novartis Investigative Site

    Piteşti, Argeş, 110438

  • Novartis Investigative Site

    Sibiu, 550245

  • Novartis Investigative Site

    Suceava, ROM, 727525

  • Novartis Investigative Site

    Târgu Mureş, Mureș County, 540124

  • Novartis Investigative Site

    Timișoara, Timiș County, 300362

  • Novartis Investigative Site

    Timișoara, 300041

  • Novartis Investigative Site

    Timișoara, 300310

Other trials in Romania

Bulgaria17 sites

  • Novartis Investigative Site

    Blagoevgrad, 2700

  • Novartis Investigative Site

    Burgas, BGR, 8018

  • Novartis Investigative Site

    Burgas, 8127

  • Novartis Investigative Site

    Gabrovo, 5300

  • Novartis Investigative Site

    Kardzhali, 6600

  • Novartis Investigative Site

    Pernik, 2300

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Plovdiv, 4002

  • Novartis Investigative Site

    Rousse, 7000

  • Novartis Investigative Site

    Sofia, BGR, 1407

  • Novartis Investigative Site

    Sofia, 1202

  • Novartis Investigative Site

    Sofia, 1233

  • Novartis Investigative Site

    Sofia, 1431

  • Novartis Investigative Site

    Sofia, 1527

  • Novartis Investigative Site

    Sofia, 1606

  • Novartis Investigative Site

    Sofia, 1709

  • Novartis Investigative Site

    Varna, 9010

Other trials in Bulgaria

India16 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380 060

  • Novartis Investigative Site

    Bikaner, Rajasthan, 334003

  • Novartis Investigative Site

    Dehradun, Uttarakhand, 248001

  • Novartis Investigative Site

    Gurgaon, Haryana, 122001

  • Novartis Investigative Site

    Hyderabad, Telangana, 500082

  • Novartis Investigative Site

    Karamsad, Gujarat, 388325

  • Novartis Investigative Site

    Kochi, Kerala, 682 018

  • Novartis Investigative Site

    Madurai, Tamil Nadu, 625107

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400012

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440009

  • Novartis Investigative Site

    Nashik, Maharashtra, 422005

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110 060

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110007

  • Novartis Investigative Site

    Pune, Maharashtra, 411001

  • Novartis Investigative Site

    Secunderabad, Telangana, 500003

  • Novartis Investigative Site

    Vadodara, Gujarat, 390022

Other trials in India

Italy16 sites

  • Novartis Investigative Site

    Bergamo, BG, 24127

  • Novartis Investigative Site

    Bologna, BO, 40133

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Catanzaro, CZ, 88100

  • Novartis Investigative Site

    Cona, FE, 44121

  • Novartis Investigative Site

    Grosseto, GR, 58100

  • Novartis Investigative Site

    Milan, MI, 20138

  • Novartis Investigative Site

    Milan, MI, 20142

  • Novartis Investigative Site

    Milan, MI, 20162

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Rimini, RN, 47900

  • Novartis Investigative Site

    Roma, RM, 00161

  • Novartis Investigative Site

    Roma, RM, 00184

  • Novartis Investigative Site

    Sanremo, IM, 18038

  • Novartis Investigative Site

    Trieste, TS, 34149

Other trials in Italy

United Kingdom14 sites

  • Novartis Investigative Site

    Basingstoke, Hampshire, RG24 9NA

  • Novartis Investigative Site

    Belfast, BT12 6BA

  • Novartis Investigative Site

    Birmingham, B9 5SS

  • Novartis Investigative Site

    Bournemouth, BH7 7DW

  • Novartis Investigative Site

    Clydebank, West Dumbartonshire, G81 4HX

  • Novartis Investigative Site

    Craigavon, Northern Ireland, BT63 5QQ

  • Novartis Investigative Site

    Glasgow, G51 4TF

  • Novartis Investigative Site

    Leeds, LS1 3EX

  • Novartis Investigative Site

    Leicester, LE3 9QP

  • Novartis Investigative Site

    Lincoln, Lincolnshire, LN2 5QY

  • Novartis Investigative Site

    Middlesbrough, TS4 3BW

  • Novartis Investigative Site

    Newcastle upon Tyne, NE7 7DN

  • Novartis Investigative Site

    Norwich, NR4 7UY

  • Novartis Investigative Site

    Worcester, WR5 1DD

Other trials in United Kingdom

Brazil13 sites

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30140 062

  • Novartis Investigative Site

    Blumenau, Santa Catarina, 89010 500

  • Novartis Investigative Site

    Campina Grande do Sul, 83430 000

  • Novartis Investigative Site

    Campinas, São Paulo, 13060 080

  • Novartis Investigative Site

    Curitiba, Paraná, 80730 150

  • Novartis Investigative Site

    Fortaleza, Ceará, 60430 370

  • Novartis Investigative Site

    Goiânia, Goiás, 74605 050

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90620 001

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 91350 200

  • Novartis Investigative Site

    São José, 8001

  • Novartis Investigative Site

    São José do Rio Preto, São Paulo, 15090 000

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403 000

  • Novartis Investigative Site

    Uberlândia, Minas Gerais, 38411 186

Other trials in Brazil

Spain12 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Badalona, Catalonia, 08916

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Cáceres, Extremadura, 10003

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

  • Novartis Investigative Site

    León, Castille and León, 24071

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Seville, Andalusia, 41014

  • Novartis Investigative Site

    Valencia, Valencia, 46010

  • Novartis Investigative Site

    Valencia, 46026

  • Novartis Investigative Site

    Villamartín, Cadiz, 11650

Other trials in Spain

Turkey (Türkiye)11 sites

  • Novartis Investigative Site

    Ankara-Cankaya, 06100

  • Novartis Investigative Site

    Istanbul, 34304

  • Novartis Investigative Site

    Istanbul, 34865

  • Novartis Investigative Site

    Izmir, 35040

  • Novartis Investigative Site

    Izmir, 35340

  • Novartis Investigative Site

    Kocaeli, 41380

  • Novartis Investigative Site

    Kucukcekmece Istanbul, 34303

  • Novartis Investigative Site

    Mersin, 33343

  • Novartis Investigative Site

    Meselik, Eskişehir, 26480

  • Novartis Investigative Site

    Sivas, 58140

  • Novartis Investigative Site

    Trabzon, 61080

Other trials in Turkey (Türkiye)

France10 sites

  • Novartis Investigative Site

    Bron, 69677

  • Novartis Investigative Site

    Chambray-lès-Tours, 37170

  • Novartis Investigative Site

    Corbeil-Essonnes, 91100

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    Marseille, 13008

  • Novartis Investigative Site

    Paris, 75010

  • Novartis Investigative Site

    Paris, 75015

  • Novartis Investigative Site

    Paris, 75877

  • Novartis Investigative Site

    Pessac, 33604

  • Novartis Investigative Site

    Toulouse, 31059

Other trials in France

Portugal10 sites

  • Novartis Investigative Site

    Almada, 2801 951

  • Novartis Investigative Site

    Braga, 4710243

  • Novartis Investigative Site

    Carnaxide, Lisbon District, 2799 523

  • Novartis Investigative Site

    Coimbra, 3041-853

  • Novartis Investigative Site

    Covilha, 6200-251

  • Novartis Investigative Site

    Faro, 8000 386

  • Novartis Investigative Site

    Guimarães, 4835 044

  • Novartis Investigative Site

    Leiria, 2410-187

  • Novartis Investigative Site

    Lisbon, 1649-035

  • Novartis Investigative Site

    Vila Real, 5000-508

Other trials in Portugal

Hungary9 sites

  • Novartis Investigative Site

    Budapest, 1027

  • Novartis Investigative Site

    Budapest, 1085

  • Novartis Investigative Site

    Budapest, 1134

  • Novartis Investigative Site

    Budapest, H 1096

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Pécs, Baranya, 7621

  • Novartis Investigative Site

    Szeged, 6725

  • Novartis Investigative Site

    Székesfehérvár, H-8000

  • Novartis Investigative Site

    Zalaegerszeg, Zala County, 8900

Other trials in Hungary

Canada8 sites

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 2E1

  • Novartis Investigative Site

    Montreal, Quebec, H1T 1C8

  • Novartis Investigative Site

    Ottawa, Ontario, K1Y 4W7

  • Novartis Investigative Site

    Sainte-Foy, Quebec, G1V 4G5

  • Novartis Investigative Site

    Terrebonne, Quebec, J6V 2H2

  • Novartis Investigative Site

    Toronto, Ontario, M5B 1W8

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G8Z 3R9

  • Novartis Investigative Site

    Victoria, British Columbia, V8R4R2

Other trials in Canada

Czechia8 sites

  • Novartis Investigative Site

    Brno-Bohunice, 625 00

  • Novartis Investigative Site

    Kladno, Czech Republic, 272 00

  • Novartis Investigative Site

    Liberec, Czech Republic, 46063

  • Novartis Investigative Site

    Plzen-Bory, 305 99

  • Novartis Investigative Site

    Prague, 100 34

  • Novartis Investigative Site

    Prague, 12808

  • Novartis Investigative Site

    Prague, 146 24

  • Novartis Investigative Site

    Zlín, Czech Republic, 762 75

Other trials in Czechia

Greece8 sites

  • Novartis Investigative Site

    Alexandroupoli, Evros, 681 00

  • Novartis Investigative Site

    Athens, GR, 115 27

  • Novartis Investigative Site

    Athens, GR, 14233

  • Novartis Investigative Site

    Athens, 115 21

  • Novartis Investigative Site

    Athens, 115 27

  • Novartis Investigative Site

    Athens, 115 28

  • Novartis Investigative Site

    Athens, 12462

  • Novartis Investigative Site

    Larissa, GR, 411 10

Other trials in Greece

Sweden8 sites

  • Novartis Investigative Site

    Goethenburg, 413 45

  • Novartis Investigative Site

    Helsingborg, 252 20

  • Novartis Investigative Site

    Helsingborg, 25232

  • Novartis Investigative Site

    Malmö, 221 85

  • Novartis Investigative Site

    Stockholm, SE, 141 86

  • Novartis Investigative Site

    Stockholm, 118 83

  • Novartis Investigative Site

    Uppsala, 751 85

  • Novartis Investigative Site

    Västerås, 72189

Other trials in Sweden

Taiwan8 sites

  • Novartis Investigative Site

    New Taipei City, 22060

  • Novartis Investigative Site

    Taichung, 40447

  • Novartis Investigative Site

    Tainan, 71004

  • Novartis Investigative Site

    Taipei, 10002

  • Novartis Investigative Site

    Taipei, 10449

  • Novartis Investigative Site

    Taipei, 11217

  • Novartis Investigative Site

    Taoyuan, 33305

  • Novartis Investigative Site

    Yilan, 26058

Other trials in Taiwan

Austria7 sites

  • Novartis Investigative Site

    Braunau am Inn, A5280

  • Novartis Investigative Site

    Graz, 8036

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020

  • Novartis Investigative Site

    Linz, A-4010

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    Sankt Pölten, 3100

  • Novartis Investigative Site

    Vienna, 1210

Other trials in Austria

Belgium7 sites

  • Novartis Investigative Site

    Aalst, 9300

  • Novartis Investigative Site

    Brasschaat, 2930

  • Novartis Investigative Site

    Edegem, Antwerpen, 2650

  • Novartis Investigative Site

    Genk, 3600

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Turnhout, 2300

  • Novartis Investigative Site

    Yvoir, 5530

Other trials in Belgium

Denmark7 sites

  • Novartis Investigative Site

    Aalborg, DK 9000

  • Novartis Investigative Site

    Glostrup Municipality, 2600

  • Novartis Investigative Site

    Herlev, 2730

  • Novartis Investigative Site

    Hvidovre, 2650

  • Novartis Investigative Site

    Svendborg, 5700

  • Novartis Investigative Site

    Vejle, 7100

  • Novartis Investigative Site

    Viborg, DK-8800

Other trials in Denmark

Mexico7 sites

  • Novartis Investigative Site

    Culiacan Sinaloa, Mexico City, 80230

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44670

  • Novartis Investigative Site

    Guadalajara, Jalisco, 45116

  • Novartis Investigative Site

    Mexico City, 02980

  • Novartis Investigative Site

    Querétaro, 76000

  • Novartis Investigative Site

    San Luis Potosí City, 78240

  • Novartis Investigative Site

    Torreón, Coahulia, 27000

Other trials in Mexico

Australia6 sites

  • Novartis Investigative Site

    Bedford Park, South Australia, 5041

  • Novartis Investigative Site

    Chemside, Queensland, 4032

  • Novartis Investigative Site

    Geelong, Victoria, 3220

  • Novartis Investigative Site

    Herston, Queensland, 4029

  • Novartis Investigative Site

    Hobart, Tasmania, 7000

  • Novartis Investigative Site

    Murdoch, Western Australia, 6150

Other trials in Australia

Colombia6 sites

  • Novartis Investigative Site

    Barranquilla, 080020

  • Novartis Investigative Site

    Bogotá, 110010

  • Novartis Investigative Site

    Bucaramanga, Santander Department, 65265

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760001

  • Novartis Investigative Site

    Medellín, Antioquia, 050001

  • Novartis Investigative Site

    Medellín, Antioquia, 6CM8+47

Other trials in Colombia

Israel6 sites

  • Novartis Investigative Site

    Ashkelon, 78278

  • Novartis Investigative Site

    Haifa, 3109601

  • Novartis Investigative Site

    Lower Galilee, Israel, 15208

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Sefad, 13100

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Slovakia6 sites

  • Novartis Investigative Site

    Banská Bystrica, SVK, 974 01

  • Novartis Investigative Site

    Bratislava, Slovak Republic, 826 06

  • Novartis Investigative Site

    Bratislava, 833 48

  • Novartis Investigative Site

    Košice, 040 11

  • Novartis Investigative Site

    Nitra, Slovak Republic, 949 01

  • Novartis Investigative Site

    Prešov, 081 81

Other trials in Slovakia

Poland5 sites

  • Novartis Investigative Site

    Bialystok, 15 276

  • Novartis Investigative Site

    Lubin, 59-301

  • Novartis Investigative Site

    Lublin, 20-718

  • Novartis Investigative Site

    Warsaw, 02-097

  • Novartis Investigative Site

    Warsaw, 02-507

Other trials in Poland

Singapore5 sites

  • Novartis Investigative Site

    Singapore, 119074

  • Novartis Investigative Site

    Singapore, 169609

  • Novartis Investigative Site

    Singapore, 308433

  • Novartis Investigative Site

    Singapore, 529889

  • Novartis Investigative Site

    Singapore, 768828

Other trials in Singapore

South Africa5 sites

  • Novartis Investigative Site

    Cape Town, Western Cape, 7500

  • Novartis Investigative Site

    Cape Town, 7925

  • Novartis Investigative Site

    George, Western Cape, 6529

  • Novartis Investigative Site

    Pinelands, Cape Town, 7405

  • Novartis Investigative Site

    Worcester, 6850

Other trials in South Africa

Peru4 sites

  • Novartis Investigative Site

    Bellavista, Lima region, CALLAO 02

  • Novartis Investigative Site

    Jesus Maria, Lima region, 11

  • Novartis Investigative Site

    Lima, 10

  • Novartis Investigative Site

    Lima Cercado, Lima region, 01

Other trials in Peru

South Korea4 sites

  • Novartis Investigative Site

    Cheongju-si, North Chungcheong, 28644

  • Novartis Investigative Site

    Gwangju, 61469

  • Novartis Investigative Site

    Seoul, 02841

  • Novartis Investigative Site

    Wŏnju, Gangwon-do, 26427

Other trials in South Korea

Switzerland4 sites

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Lucerne, CH 6000

  • Novartis Investigative Site

    Lugano, 6903

  • Novartis Investigative Site

    Sankt Gallen, 9007

Other trials in Switzerland

Thailand4 sites

  • Novartis Investigative Site

    Bangkok, THA, 10330

  • Novartis Investigative Site

    Bangkok, 10700

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Khon Kaen, THA, 40002

Other trials in Thailand

Croatia3 sites

  • Novartis Investigative Site

    Čakovec, 40000

  • Novartis Investigative Site

    Zagreb, HRV, 10000

  • Novartis Investigative Site

    Zagreb, 10000

Other trials in Croatia

Finland3 sites

  • Novartis Investigative Site

    Jyväskylä, 40620

  • Novartis Investigative Site

    Kaupio, 70210

  • Novartis Investigative Site

    Tampere, 33520

Other trials in Finland

Norway3 sites

  • Novartis Investigative Site

    Grålum, 1714

  • Novartis Investigative Site

    Oslo, 0372

  • Novartis Investigative Site

    Stavanger, 4068

Other trials in Norway

Philippines3 sites

  • Novartis Investigative Site

    Iloilo City, Iloilo, 5000

  • Novartis Investigative Site

    Manila, National Capital Region, 1000

  • Novartis Investigative Site

    Quezon City, Manila, 1100

Other trials in Philippines

About this study

Official 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 Acute Myocardial Infarction (AMI)

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.

Read the detailed description

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.

Being tested
LCZ696 (sacubitril/valsartan), Ramipril, Placebo of LCZ696, Placebo of ramipril, Valsartan
Keywords
Spontaneous AMI, HF hospitalization, outpatient HF, LV systolic dysfunction, pulmonary congestion, STEMI, NSTEMI, randomized clinical trial, LCZ696, ramipril
Medical subject headings
Ventricular Dysfunction, Left, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LCZ696 (sacubitril/valsartan)Drug

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

  • RamiprilDrug

    Ramipril 1.25 mg, 2.5 mg, and 5 mg oral capsules

  • Placebo of LCZ696Drug

    Matching placebo of LCZ696 tablets

  • Placebo of ramiprilDrug

    Matching placebo of ramipril capsule

  • ValsartanDrug

    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

  • Placebo of valsartanDrug

    matching placebo of valsartan for one day to patients who will be randomized to received ramipril

Study groups in NCT02924727
Study groupRoleWhat they receive
LCZ696 (sacubitril/valsartan)ExperimentalFollowing 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.
Receives: Drug: LCZ696 (sacubitril/valsartan); Drug: Placebo of ramipril; Drug: Valsartan
RamiprilActive comparatorFollowing 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.
Receives: Drug: Ramipril; Drug: Placebo of LCZ696; Drug: Placebo of valsartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint

    A confirmed composite endpoint includes cardiovascular (CV) death, heart failure (HF) hospitalization, or outpatient heart failure

    Measured: From randomization to first occurrence (up to approximately 43 months)

Secondary outcomes (5)

  1. Number of Participants With a Confirmed Composite of CV Death or HF Hospitalization

    A confirmed composite endpoint for this outcome measure includes cardiovascular death or heart failure hospitalization.

    Measured: Time from randomization to first occurrence (up to approximately 43 months)

  2. Number of Participants With a Confirmed Composite of HF Hospitalization or Outpatient HF

    A confirmed composite endpoint includes first occurrence of heart failure hospitalization or outpatient heart failure

    Measured: Time from randomization to first occurrence (approximately up to 43 months)

  3. Number of Participants With 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

    Measured: Time from randomization to first occurrence (approximately up to 43 months)

  4. Total Number of Confirmed Composite Endpoints

    A confirmed composite endpoint includes cardiovascular death, heart failure hospitalization, non-fatal spontaneous MI hospitalization, and non-fatal stroke hospitalization

    Measured: Time from randomization to end of study (approximately up to 43 months)

  5. All-cause Mortality for Full Analysis Set (FAS)

    All-cause mortality defined as deaths related to Cardiovascular (CV) and non-CV events for patients in the Full Analysis Set up to a cut-off date of 31-Dec-2020.

    Measured: Time from randomization to death (approximately up to 43 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2016 (estimated)
  2. Study start9 Dec 2016
  3. Primary completion26 Feb 2021
  4. Study completion26 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
5,669 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02924727
Sponsor's protocol ID
CLCZ696G2301
Other IDs
2016-002154-20, 2016
Acronym
PARADISE-MI
Status last verified
Jun 2023
First submitted
4 Oct 2016
Last updated
22 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Curtain JP, Pfeffer MA, Braunwald E, Claggett BL, Granger CB, Kober L, Lewis EF, Maggioni AP, Mann DL, Rouleau JL, Solomon SD, Steg PG, Finn PV, Fernandez A, Jering KS, McMurray JJV. Rates of Sudden Death After Myocardial Infarction-Insights From the VALIANT and PARADISE-MI Trials. JAMA Cardiol. 2024 Oct 1;9(10):928-933. doi: 10.1001/jamacardio.2024.2356.

    PubMed 39110471

  • Mann DL, Nicolas J, Claggett B, Miao ZM, Granger CB, Kerkar P, Kober L, Lewis EF, McMurray JJV, Maggioni AP, Nunez J, Ntsekhe M, Rouleau JL, Sim D, Solomon SD, Steg PG, van der Meer P, Braunwald E, Pfeffer MA, Mehran R. Angiotensin Receptor-Neprilysin Inhibition in Patients With STEMI vs NSTEMI. J Am Coll Cardiol. 2024 Mar 5;83(9):904-914. doi: 10.1016/j.jacc.2024.01.002.

    PubMed 38418004

  • Petrie MC, Rouleau JL, Claggett B, Jering K, van der Meer P, Kober L, Miao ZM, Lewis E, Granger C, De Pasqulae CG, Mann D, Steg PG, Maggioni A, Amir O, Lefkowitz M, Braunwald E, Solomon SD, McMurray JJV, Pfeffer MA. Pulmonary Congestion and Left Ventricular Dysfunction After Myocardial Infarction: Insights From the PARADISE-MI Trial. Circulation. 2024 Jan 23;149(4):335-338. doi: 10.1161/CIRCULATIONAHA.123.066163. Epub 2024 Jan 22. No abstract available.

    PubMed 38252738

  • Schou M, Claggett B, Miao ZM, Fernandez A, Filippatos G, Granger C, Jering K, Maggioni AP, McCausland F, Villota JN, Rouleau JL, Mody FV, van der Meer P, Vinereanu D, McGrath M, Zhou Y, Mann DL, Solomon SD, Steg PG, Braunwald E, McMurray JJV, Pfeffer MA, Kober L. Sacubitril/valsartan compared to ramipril in high-risk post-myocardial infarction patients stratified according to use of mineralocorticoid receptor antagonists: Insight from the PARADISE MI trial. Eur J Heart Fail. 2024 Jan;26(1):130-139. doi: 10.1002/ejhf.3079. Epub 2023 Nov 29.

    PubMed 37933184

  • Wang X, Jering KS, Cikes M, Tokmakova MP, Mehran R, Han Y, East C, Mody FV, Wang Y, Lewis EF, Claggett B, McMurray JJV, Granger CB, Pfeffer MA, Solomon SD. Sex Differences in Clinical Characteristics and Outcomes After Myocardial Infarction With Low Ejection Fraction: Insights From PARADISE-MI. J Am Heart Assoc. 2023 Sep 5;12(17):e028942. doi: 10.1161/JAHA.122.028942. Epub 2023 Aug 23.

    PubMed 37609931

  • Jering KS, Claggett BL, Pfeffer MA, Granger CB, Kober L, Lewis EF, Maggioni AP, Mann DL, McMurray JJV, Prescott MF, Rouleau JL, Solomon SD, Steg PG, von Lewinski D, Braunwald E. Prognostic Importance of NT-proBNP (N-Terminal Pro-B-Type Natriuretic Peptide) Following High-Risk Myocardial Infarction in the PARADISE-MI Trial. Circ Heart Fail. 2023 May;16(5):e010259. doi: 10.1161/CIRCHEARTFAILURE.122.010259. Epub 2023 May 1.

    PubMed 37125529

  • Mehran R, Steg PG, Pfeffer MA, Jering K, Claggett B, Lewis EF, Granger C, Kober L, Maggioni A, Mann DL, McMurray JJV, Rouleau JL, Solomon SD, Ducrocq G, Berwanger O, De Pasquale CG, Landmesser U, Petrie M, Leng DSK, van der Meer P, Lefkowitz M, Zhou Y, Braunwald E. The Effects of Angiotensin Receptor-Neprilysin Inhibition on Major Coronary Events in Patients With Acute Myocardial Infarction: Insights From the PARADISE-MI Trial. Circulation. 2022 Dec 6;146(23):1749-1757. doi: 10.1161/CIRCULATIONAHA.122.060841. Epub 2022 Nov 2.

    PubMed 36321459

  • Shah AM, Claggett B, Prasad N, Li G, Volquez M, Jering K, Cikes M, Kovacs A, Mullens W, Nicolau JC, Kober L, van der Meer P, Jhund PS, Ibram G, Lefkowitz M, Zhou Y, Solomon SD, Pfeffer MA. Impact of Sacubitril/Valsartan Compared With Ramipril on Cardiac Structure and Function After Acute Myocardial Infarction: The PARADISE-MI Echocardiographic Substudy. Circulation. 2022 Oct 4;146(14):1067-1081. doi: 10.1161/CIRCULATIONAHA.122.059210. Epub 2022 Sep 9.

    PubMed 36082663

  • Pfeffer MA, Claggett B, Lewis EF, Granger CB, Kober L, Maggioni AP, Mann DL, McMurray JJV, Rouleau JL, Solomon SD, Steg PG, Berwanger O, Cikes M, De Pasquale CG, Fernandez A, Filippatos G, Jering K, Landmesser U, Menon V, Merkely B, Petrie MC, Petrov I, Schou M, Senni M, Sim D, van der Meer P, Lefkowitz M, Zhou Y, Wang Y, Braunwald E. Impact of Sacubitril/Valsartan Versus Ramipril on Total Heart Failure Events in the PARADISE-MI Trial. Circulation. 2022 Jan 4;145(1):87-89. doi: 10.1161/CIRCULATIONAHA.121.057429. Epub 2021 Nov 19. No abstract available.

    PubMed 34797725

  • Pfeffer MA, Claggett B, Lewis EF, Granger CB, Kober L, Maggioni AP, Mann DL, McMurray JJV, Rouleau JL, Solomon SD, Steg PG, Berwanger O, Cikes M, De Pasquale CG, East C, Fernandez A, Jering K, Landmesser U, Mehran R, Merkely B, Vaghaiwalla Mody F, Petrie MC, Petrov I, Schou M, Senni M, Sim D, van der Meer P, Lefkowitz M, Zhou Y, Gong J, Braunwald E; PARADISE-MI Investigators and Committees. Angiotensin Receptor-Neprilysin Inhibition in Acute Myocardial Infarction. N Engl J Med. 2021 Nov 11;385(20):1845-1855. doi: 10.1056/NEJMoa2104508.

    PubMed 34758252

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LCZ696 (sacubitril/valsartan), Ramipril and Valsartan in people with Acute Myocardial Infarction, run by Novartis Pharmaceuticals at 486 sites in 41 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 486 sites in United States, Germany, China, Russia, Netherlands and 36 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint (time frame: From randomization to first occurrence (up to approximately 43 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02924727, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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