Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI
NCT ID: NCT02924727
Last Updated: 2023-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
5669 participants
INTERVENTIONAL
2016-12-09
2021-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
LCZ696 (sacubitril/valsartan)
LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively
Placebo of ramipril
Matching placebo of ramipril capsule
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
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.
Ramipril
Ramipril 1.25 mg, 2.5 mg, and 5 mg oral capsules
Placebo of LCZ696
Matching placebo of LCZ696 tablets
Placebo of valsartan
matching placebo of valsartan for one day to patients who will be randomized to received ramipril
Interventions
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LCZ696 (sacubitril/valsartan)
LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively
Ramipril
Ramipril 1.25 mg, 2.5 mg, and 5 mg oral capsules
Placebo of LCZ696
Matching placebo of LCZ696 tablets
Placebo of ramipril
Matching placebo of ramipril capsule
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
Placebo of valsartan
matching placebo of valsartan for one day to patients who will be randomized to received ramipril
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Gilbert, Arizona, United States
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Bakersfield, California, United States
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Hollywood, Florida, United States
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Jacksonville Beach, Florida, United States
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Cumming, Georgia, United States
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Johns Creek, Georgia, United States
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Muncie, Indiana, United States
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Salta, Salta Province, Argentina
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Shengyang, Liaoning, China
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Jinan, Shandong, China
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Shanghai, Shanghai Municipality, China
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Zhujing, Shanghai Municipality, China
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Xian, Shanxi, China
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Tianjin, Tianjin Municipality, China
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Wenzhou, Zhejiang, China
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Bucaramanga, Santander Department, Colombia
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Cali, Valle del Cauca Department, Colombia
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Zagreb, HRV, Croatia
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Čakovec, , Croatia
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Zagreb, , Croatia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Aalborg, , Denmark
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Glostrup Municipality, , Denmark
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Herlev, , Denmark
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Hvidovre, , Denmark
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Svendborg, , Denmark
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Jyväskylä, , Finland
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Tampere, , Finland
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Marseille, , France
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Paris, , France
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Paris, , France
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Pessac, , France
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Toulouse, , France
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Bad Krozingen, , Germany
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Berlin, , Germany
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Bremen, , Germany
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Coburg, , Germany
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Cologne, , Germany
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Dresden, , Germany
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Erfurt, , Germany
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Essen, , Germany
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Esslingen am Neckar, , Germany
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Frankfurt, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Greifswald, , Germany
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Hennigsdorf, , Germany
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Kiel, , Germany
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Langen, , Germany
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Leverkusen, , Germany
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Ludwigshafen, , Germany
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Mönchengladbach, , Germany
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Rüsselsheim am Main, , Germany
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Würzburg, , Germany
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Lower Galilee, Israel, Israel
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Napoli, , Italy
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Sneek, The Netherlands, Netherlands
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Alkmaar, , Netherlands
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Almelo, , Netherlands
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Amersfoort, , Netherlands
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Amsterdam, , Netherlands
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Beverwijk, , Netherlands
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Breda, , Netherlands
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Ede, , Netherlands
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Gouda, , Netherlands
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Groningen, , Netherlands
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Heemstede, , Netherlands
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Leeuwarden, , Netherlands
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Leiderdorp, , Netherlands
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Rotterdam, , Netherlands
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Rotterdam, , Netherlands
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Rotterdam, , Netherlands
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Tilburg, , Netherlands
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Uden, , Netherlands
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Veldhoven, , Netherlands
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Venlo, , Netherlands
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Zutphen, , Netherlands
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Zwolle, , Netherlands
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Grålum, , Norway
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Oslo, , Norway
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Stavanger, , Norway
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Bellavista, Lima region, Peru
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Jesus Maria, Lima region, Peru
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Lima Cercado, Lima region, Peru
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Lima, , Peru
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Iloilo City, Iloilo, Philippines
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002154-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLCZ696G2301
Identifier Type: -
Identifier Source: org_study_id
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