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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:December 9, 2016
End Date:July 9, 2020
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

Use our guide to learn which trials are right for you!

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

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..


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
We found this trial at
109
sites
Saint Cloud, Minnesota 56303
?
mi
from
Saint Cloud, MN
Click here to add this to my saved trials
Alexandria, Louisiana 71301
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
Annapolis, Maryland 21401
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78759
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bakersfield, California 93301
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bangor, Maine 04401
?
mi
from
Bangor, ME
Click here to add this to my saved trials
Baton Rouge, Louisiana 70808
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Bellevue, Washington 98004
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Birmingham, Alabama 35209
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boise, Idaho 83712
?
mi
from
Boise, ID
Click here to add this to my saved trials
Brandon, Florida 33511
?
mi
from
Brandon, FL
Click here to add this to my saved trials
Brooklyn, New York 11218
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Caba, Buenos Aires
?
mi
from
Caba,
Click here to add this to my saved trials
Camp Hill, Pennsylvania 17011
?
mi
from
Camp Hill, PA
Click here to add this to my saved trials
Canton, Ohio 44718
?
mi
from
Canton, OH
Click here to add this to my saved trials
Carmichael, California 95608
?
mi
from
Carmichael, CA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29407
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28277
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22904
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clackamas, Oregon 97015
?
mi
from
Clackamas, OR
Click here to add this to my saved trials
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Coeur d'Alene, Idaho 83814
?
mi
from
Coeur d'Alene, ID
Click here to add this to my saved trials
Columbia, Maryland 21044
?
mi
from
Columbia, MD
Click here to add this to my saved trials
Columbia, South Carolina 29201
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Covington, Louisiana 70433
?
mi
from
Covington, LA
Click here to add this to my saved trials
Cumming, Georgia 30041
?
mi
from
Cumming, GA
Click here to add this to my saved trials
Dallas, Texas 75216
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Danville, Virginia 24541
?
mi
from
Danville, VA
Click here to add this to my saved trials
Davenport, Iowa 52803
?
mi
from
Davenport, IA
Click here to add this to my saved trials
Daytona Beach, Florida 32117
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Duluth, Minnesota 55805
?
mi
from
Duluth, MN
Click here to add this to my saved trials
Durham, North Carolina 27710
?
mi
from
Durham, NC
Click here to add this to my saved trials
Erie, Pennsylvania 16506
?
mi
from
Erie, PA
Click here to add this to my saved trials
Falls Church, Virginia 22042
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Flushing, New York 11355
?
mi
from
Flushing, NY
Click here to add this to my saved trials
Frederick, Maryland 21702
?
mi
from
Frederick, MD
Click here to add this to my saved trials
Gilbert, Arizona 85234
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
Grand Blanc, Michigan 48439
?
mi
from
Grand Blanc, MI
Click here to add this to my saved trials
Grand Forks, North Dakota 58201
?
mi
from
Grand Forks, ND
Click here to add this to my saved trials
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Hackensack, New Jersey 07601
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
Hammond, Louisiana 70403
?
mi
from
Hammond, LA
Click here to add this to my saved trials
Hattiesburg, Mississippi 39401
?
mi
from
Hattiesburg, MS
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92647
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Huntsville, Alabama 35801
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Iowa City, Iowa 52240
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Jackson, Mississippi 39209
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Jacksonville Beach, Florida 32050
?
mi
from
Jacksonville Beach, FL
Click here to add this to my saved trials
Kalamazoo, Michigan 49048
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Knoxville, Tennessee 37934
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lansing, Michigan 48910
?
mi
from
Lansing, MI
Click here to add this to my saved trials
Lebanon, New Hampshire 03756
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Lee's Summit, Missouri 64086
?
mi
from
Lee's Summit, MO
Click here to add this to my saved trials
Lincoln, Nebraska 68506
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Los Alamitos, California 90720
?
mi
from
Los Alamitos, CA
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Lynchburg, Virginia 24501
?
mi
from
Lynchburg, VA
Click here to add this to my saved trials
Manassas, Virginia 20109
?
mi
from
Manassas, VA
Click here to add this to my saved trials
Manitowoc, Wisconsin 54221
?
mi
from
Manitowoc, WI
Click here to add this to my saved trials
Medford, Oregon 97504
?
mi
from
Medford, OR
Click here to add this to my saved trials
Midland, Michigan 48640
?
mi
from
Midland, MI
Click here to add this to my saved trials
Muncie, Indiana 47303
?
mi
from
Muncie, IN
Click here to add this to my saved trials
Munster, Indiana 46321
?
mi
from
Munster, IN
Click here to add this to my saved trials
Nashville, Tennessee 37205
?
mi
from
Nashville, TN
Click here to add this to my saved trials
230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
?
mi
from
New York, NY
Click here to add this to my saved trials
Newark, New Jersey 07103
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Northridge, California 91325
?
mi
from
Northridge, CA
Click here to add this to my saved trials
Ocala, Florida 34471
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Omaha, Nebraska 68144
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Petoskey, Michigan 49770
?
mi
from
Petoskey, MI
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Poughkeepsie, New York 12601
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
Rapid City, South Dakota 57701
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
Richmond, Indiana 47374
?
mi
from
Richmond, IN
Click here to add this to my saved trials
Richmond, Virginia 23249
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Roanoke, Virginia 24014
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
Robbinsdale, Minnesota 55422
?
mi
from
Robbinsdale, MN
Click here to add this to my saved trials
Rockville, Maryland 20852
?
mi
from
Rockville, MD
Click here to add this to my saved trials
Saginaw, Michigan 48601
?
mi
from
Saginaw, MI
Click here to add this to my saved trials
Saint Louis, Missouri 63128
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Paul, Minnesota 55102
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
San Francisco, California 94121
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Rosa, California 95405
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
Seattle, Washington 98103
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Slidell, Louisiana 70458
?
mi
from
Slidell, LA
Click here to add this to my saved trials
Southfield, Michigan 48075
?
mi
from
Southfield, MI
Click here to add this to my saved trials
Springfield, Illinois 62703
?
mi
from
Springfield, IL
Click here to add this to my saved trials
Springfield, Massachusetts 01104
?
mi
from
Springfield, MA
Click here to add this to my saved trials
Stony Brook, New York 11794
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials