Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI
PARADISE-MI
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)
2 other identifiers
interventional
5,669
40 countries
479
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2016
Typical duration for phase_3
479 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2016
CompletedFirst Posted
Study publicly available on registry
October 5, 2016
CompletedStudy Start
First participant enrolled
December 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2021
CompletedResults Posted
Study results publicly available
June 22, 2023
CompletedJune 22, 2023
June 1, 2023
4.2 years
October 4, 2016
January 20, 2022
June 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
From randomization to first occurrence (up to approximately 43 months)
Secondary Outcomes (5)
Number of Participants With a Confirmed Composite of CV Death or HF Hospitalization
Time from randomization to first occurrence (up to approximately 43 months)
Number of Participants With a Confirmed Composite of HF Hospitalization or Outpatient HF
Time from randomization to first occurrence (approximately up to 43 months)
Number of Participants With a Confirmed Composite of CV Death, Non-fatal Spontaneous Myocardial Infarction or Non-fatal Stroke
Time from randomization to first occurrence (approximately up to 43 months)
Total Number of Confirmed Composite Endpoints
Time from randomization to end of study (approximately up to 43 months)
All-cause Mortality for Full Analysis Set (FAS)
Time from randomization to death (approximately up to 43 months)
Study Arms (2)
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.
Ramipril
ACTIVE 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.
Interventions
LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively
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
matching placebo of valsartan for one day to patients who will be randomized to received ramipril
Eligibility Criteria
You may qualify if:
- 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:
- 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:
- +3 more criteria
You may not qualify if:
- 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
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (486)
Novartis Investigative Site
Birmingham, Alabama, 35243, United States
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Birmingham, Alabama, 35294-2041, United States
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Huntsville, Alabama, 35801, United States
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Gilbert, Arizona, 85297, United States
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Bakersfield, California, 93301, United States
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Carmichael, California, 95608, United States
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Los Alamitos, California, 90720, United States
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Northridge, California, 91325, United States
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Orange, California, 92868, United States
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San Francisco, California, 94143, United States
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Sylmar, California, 91342, United States
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Brandon, Florida, 33511, United States
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Hollywood, Florida, 33312, United States
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Jacksonville Beach, Florida, 32050, United States
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Ocala, Florida, 34480, United States
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Cumming, Georgia, 30041, United States
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Johns Creek, Georgia, 30024, United States
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Thomasville, Georgia, 31792, United States
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Boise, Idaho, 83702, United States
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Coeur d'Alene, Idaho, 83814, United States
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Muncie, Indiana, 47303-3400, United States
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Munster, Indiana, 46321, United States
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Richmond, Indiana, 47374, United States
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Iowa City, Iowa, 52242, United States
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Alexandria, Louisiana, 71301, United States
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Baton Rouge, Louisiana, 70808, United States
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Covington, Louisiana, 70433, United States
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Hammond, Louisiana, 70403, United States
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Slidell, Louisiana, 70458, United States
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Bangor, Maine, 04401, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21218, United States
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Rockville, Maryland, 20850, United States
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Detroit, Michigan, 48201, United States
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Kalamazoo, Michigan, 49008, United States
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Lansing, Michigan, 48912, United States
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Petoskey, Michigan, 49770, United States
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Saginaw, Michigan, 48601, United States
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Southfield, Michigan, 48075, United States
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Duluth, Minnesota, 55805, United States
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Robbinsdale, Minnesota, 55422, United States
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Saint Cloud, Minnesota, 56303, United States
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Saint Paul, Minnesota, 55101, United States
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Hattiesburg, Mississippi, 39401, United States
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Jackson, Mississippi, 39216, United States
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Lee's Summit, Missouri, 64064, United States
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North Kansas City, Missouri, 64116, United States
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Springfield, Missouri, 65804, United States
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Lincoln, Nebraska, 68506, United States
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Lincoln, Nebraska, 68526, United States
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Omaha, Nebraska, 68114, United States
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Lebanon, New Hampshire, 03756, United States
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Hackensack, New Jersey, 07601, United States
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Flushing, New York, 11355, United States
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New York, New York, 10016, United States
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New York, New York, 10029, United States
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Valhalla, New York, 10595, United States
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Chapel Hill, North Carolina, 27599, United States
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Charlotte, North Carolina, 28204, United States
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Durham, North Carolina, 27710, United States
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Grand Forks, North Dakota, 58201, United States
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Canton, Ohio, 44710, United States
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Cincinnati, Ohio, 45220, United States
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Medford, Oregon, 97504, United States
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Erie, Pennsylvania, 16550, United States
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Hershey, Pennsylvania, 17033, United States
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York, Pennsylvania, 17403, United States
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Charleston, South Carolina, 29403, United States
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Columbia, South Carolina, 29203, United States
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Greenville, South Carolina, 29607, United States
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Rapid City, South Dakota, 57701, United States
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Knoxville, Tennessee, 37917, United States
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Nashville, Tennessee, 37212, United States
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Dallas, Texas, 75226, United States
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Houston, Texas, 77030, United States
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Webster, Texas, 77598, United States
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Danville, Virginia, 24541, United States
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Falls Church, Virginia, 22042, United States
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Lynchburg, Virginia, 24501, United States
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Manassas, Virginia, 20109, United States
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Bellevue, Washington, 98004, United States
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Caba, Buenos Aires, C1280AEB, Argentina
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La Plata, Buenos Aires, B1900AWT, Argentina
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Buenos Aires, Buenos Aires F.D., C1078AAI, Argentina
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Salta, Salta Province, A4406BPF, Argentina
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San Miguel de Tucumán, San Miguel de Tucuman, T4000ICL, Argentina
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Rosario, Santa Fe Province, C2000DSR, Argentina
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Rosario, Santa Fe Province, S2000DSV, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina
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Buenos Aires, B1602ABQ, Argentina
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Buenos Aires, B1846BMF, Argentina
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Buenos Aires, C1405CNF, Argentina
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Buenos Aires, C1428DCO, Argentina
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Buenos Aires, C1430EGF, Argentina
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Corrientes, W3400, Argentina
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Córdoba, X5000, Argentina
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Córdoba, X5003DCP, Argentina
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Córdoba, X5004BAL, Argentina
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Córdoba, X5006CBI, Argentina
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Formosa, P3600, Argentina
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San Luis, D5702JRS, Argentina
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Santa Fe, S3000FUJ, Argentina
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Chemside, Queensland, 4032, Australia
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Herston, Queensland, 4029, Australia
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Bedford Park, South Australia, 5041, Australia
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Hobart, Tasmania, 7000, Australia
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Geelong, Victoria, 3220, Australia
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Murdoch, Western Australia, 6150, Australia
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Innsbruck, Tyrol, 6020, Austria
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Braunau am Inn, A5280, Austria
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Graz, 8036, Austria
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Linz, A-4010, Austria
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Salzburg, 5020, Austria
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Sankt Pölten, 3100, Austria
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Vienna, 1210, Austria
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Edegem, Antwerpen, 2650, Belgium
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Aalst, 9300, Belgium
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Brasschaat, 2930, Belgium
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Genk, 3600, Belgium
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Leuven, 3000, Belgium
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Turnhout, 2300, Belgium
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Yvoir, 5530, Belgium
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Fortaleza, Ceará, 60430 370, Brazil
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Goiânia, Goiás, 74605 050, Brazil
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Belo Horizonte, Minas Gerais, 30140 062, Brazil
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Uberlândia, Minas Gerais, 38411 186, Brazil
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Curitiba, Paraná, 80730 150, Brazil
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Porto Alegre, Rio Grande do Sul, 90620 001, Brazil
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Porto Alegre, Rio Grande do Sul, 91350 200, Brazil
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Blumenau, Santa Catarina, 89010 500, Brazil
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Campinas, São Paulo, 13060 080, Brazil
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São José do Rio Preto, São Paulo, 15090 000, Brazil
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São Paulo, São Paulo, 05403 000, Brazil
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Campina Grande do Sul, 83430 000, Brazil
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São José, 8001, Brazil
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Burgas, BGR, 8018, Bulgaria
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Sofia, BGR, 1407, Bulgaria
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Blagoevgrad, 2700, Bulgaria
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Burgas, 8127, Bulgaria
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Gabrovo, 5300, Bulgaria
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Kardzhali, 6600, Bulgaria
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Pernik, 2300, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Rousse, 7000, Bulgaria
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Sofia, 1202, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1709, Bulgaria
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Varna, 9010, Bulgaria
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Edmonton, Alberta, T6G 2E1, Canada
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Victoria, British Columbia, V8R4R2, Canada
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Ottawa, Ontario, K1Y 4W7, Canada
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Toronto, Ontario, M5B 1W8, Canada
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Montreal, Quebec, H1T 1C8, Canada
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Sainte-Foy, Quebec, G1V 4G5, Canada
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Terrebonne, Quebec, J6V 2H2, Canada
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Trois-Rivières, Quebec, G8Z 3R9, Canada
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Beijing, Beijing Municipality, 100037, China
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Xicheng, Beijing Municipality, 100044, China
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Lanzhou, Gansu, 730030, China
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Guangzhou, Guangdong, 51000, China
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Guangzhou, Guangdong, 510080, China
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Shijiazhuang, Hebei, 050000, China
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Harbin, Heilongjiang, 150000, China
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Wuhan, Hubei, 430060, China
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Changsha, Hunan, 410011, China
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Nanjing, Jiangsu, 210008, China
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Nanjing, Jiangsu, 210029, China
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Changchun, Jilin, 130021, China
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Yanji, Jilin, 133001, China
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Shengyang, Liaoning, 110016, China
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Jinan, Shandong, 250013, China
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Shanghai, Shanghai Municipality, 200120, China
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Zhujing, Shanghai Municipality, 201508, China
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Xian, Shanxi, 710061, China
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Tianjin, Tianjin Municipality, 300121, China
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Wenzhou, Zhejiang, 325000, China
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Beijing, 100029, China
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Beijing, 100050, China
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Beijing, 100191, China
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Shanghai, 200080, China
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Tianjin, 300052, China
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Wuhan, 430022, China
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Medellín, Antioquia, 050001, Colombia
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Medellín, Antioquia, 6CM8+47, Colombia
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Bucaramanga, Santander Department, 65265, Colombia
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Cali, Valle del Cauca Department, 760001, Colombia
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Barranquilla, 080020, Colombia
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Bogotá, 110010, Colombia
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Zagreb, HRV, 10000, Croatia
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Čakovec, 40000, Croatia
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Zagreb, 10000, Croatia
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Kladno, Czech Republic, 272 00, Czechia
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Liberec, Czech Republic, 46063, Czechia
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Zlín, Czech Republic, 762 75, Czechia
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Brno-Bohunice, 625 00, Czechia
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Plzen-Bory, 305 99, Czechia
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Prague, 100 34, Czechia
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Prague, 12808, Czechia
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Prague, 146 24, Czechia
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Aalborg, DK 9000, Denmark
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Glostrup Municipality, 2600, Denmark
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Herlev, 2730, Denmark
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Hvidovre, 2650, Denmark
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Svendborg, 5700, Denmark
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Vejle, 7100, Denmark
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Viborg, DK-8800, Denmark
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Jyväskylä, 40620, Finland
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Kaupio, 70210, Finland
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Tampere, 33520, Finland
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Bron, 69677, France
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Chambray-lès-Tours, 37170, France
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Corbeil-Essonnes, 91100, France
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Grenoble, 38043, France
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Marseille, 13008, France
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Paris, 75010, France
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Paris, 75015, France
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Paris, 75877, France
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Pessac, 33604, France
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Toulouse, 31059, France
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Augsburg, 86179, Germany
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Bad Krozingen, 79189, Germany
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Berlin, 13353, Germany
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Bremen, 28277, Germany
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Coburg, 96450, Germany
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Cologne, 50937, Germany
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Dresden, 01307, Germany
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Erfurt, 99089, Germany
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Essen, 45147, Germany
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Esslingen am Neckar, 73730, Germany
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Frankfurt, 60590, Germany
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Frankfurt, 65929, Germany
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Freiburg im Breisgau, 79106, Germany
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Greifswald, 17475, Germany
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Gütersloh, 33332, Germany
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Hennigsdorf, 16761, Germany
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Kiel, 24105, Germany
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Koeln-Nippes, 50733, Germany
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Langen, 63225, Germany
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Leverkusen, 51375, Germany
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Ludwigshafen, 67063, Germany
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Mönchengladbach, 41063, Germany
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Neuss, 41464, Germany
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Neuwied, 56564, Germany
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Riesa, 01589, Germany
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Rüsselsheim am Main, 65428, Germany
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Stadtlohn, 48703, Germany
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Vechta, 49377, Germany
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Villingen-Schwenningen, 78052, Germany
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Witten, 58455, Germany
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Würzburg, 97080, Germany
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Alexandroupoli, Evros, 681 00, Greece
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Athens, GR, 115 27, Greece
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Athens, GR, 14233, Greece
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Larissa, GR, 411 10, Greece
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Athens, 115 21, Greece
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Athens, 115 27, Greece
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Athens, 115 28, Greece
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Athens, 12462, Greece
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Pécs, Baranya, 7621, Hungary
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Zalaegerszeg, Zala County, 8900, Hungary
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Budapest, 1027, Hungary
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Budapest, 1085, Hungary
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Budapest, 1134, Hungary
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Budapest, H 1096, Hungary
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Debrecen, 4032, Hungary
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Szeged, 6725, Hungary
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Székesfehérvár, H-8000, Hungary
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Ahmedabad, Gujarat, 380 060, India
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Karamsad, Gujarat, 388325, India
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Vadodara, Gujarat, 390022, India
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Gurgaon, Haryana, 122001, India
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Kochi, Kerala, 682 018, India
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Mumbai, Maharashtra, 400012, India
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Nagpur, Maharashtra, 440009, India
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Nashik, Maharashtra, 422005, India
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Pune, Maharashtra, 411001, India
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New Delhi, National Capital Territory of Delhi, 110 060, India
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New Delhi, National Capital Territory of Delhi, 110007, India
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Bikaner, Rajasthan, 334003, India
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Madurai, Tamil Nadu, 625107, India
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Hyderabad, Telangana, 500082, India
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Secunderabad, Telangana, 500003, India
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Dehradun, Uttarakhand, 248001, India
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Lower Galilee, Israel, 15208, Israel
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Ashkelon, 78278, Israel
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Haifa, 3109601, Israel
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Petah Tikva, 49100, Israel
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Sefad, 13100, Israel
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Tel Aviv, 6423906, Israel
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Bergamo, BG, 24127, Italy
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Bologna, BO, 40133, Italy
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Brescia, BS, 25123, Italy
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Catanzaro, CZ, 88100, Italy
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Cona, FE, 44121, Italy
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Grosseto, GR, 58100, Italy
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Sanremo, IM, 18038, Italy
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Milan, MI, 20138, Italy
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Milan, MI, 20142, Italy
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Milan, MI, 20162, Italy
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Pavia, PV, 27100, Italy
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Roma, RM, 00161, Italy
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Roma, RM, 00184, Italy
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Rimini, RN, 47900, Italy
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Trieste, TS, 34149, Italy
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Napoli, 80131, Italy
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Torreón, Coahulia, 27000, Mexico
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Guadalajara, Jalisco, 44670, Mexico
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Related Publications (9)
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.
PMID: 39110471DERIVEDMann 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.
PMID: 38418004DERIVEDPetrie 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.
PMID: 38252738DERIVEDWang 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.
PMID: 37609931DERIVEDJering 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.
PMID: 37125529DERIVEDMehran 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.
PMID: 36321459DERIVEDShah 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.
PMID: 36082663DERIVEDPfeffer 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.
PMID: 34797725DERIVEDPfeffer 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.
PMID: 34758252DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
In this study there were 25 patients who did not take study treatment after randomization, and thus were not included in the safety set.
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2016
First Posted
October 5, 2016
Study Start
December 9, 2016
Primary Completion
February 26, 2021
Study Completion
February 26, 2021
Last Updated
June 22, 2023
Results First Posted
June 22, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
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