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EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction (EVOLVE-MI)

Primary Purpose

Cardiovascular Disease, Myocardial Infarction, Stroke

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Routine Lipid Management
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring Acute Myocardial Infarction, Cardiovascular Disease, Stroke, Coronary revascularization, Evolocumab, STEMI, NSTEMI, Heart Attack, Pragmatic

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease

Exclusion Criteria:

  • Participants requiring invasive hemodynamic and/or vasopressor/inotropic support at the time of screening
  • Participants with elevated biomarkers of myocardial injury due to secondary/nonatherosclerotic etiology (eg, sepsis, atrial fibrillation, vasospasm, decompensated heart failure, uncontrolled hypertension)

Sites / Locations

  • Uab Heart and Vascular ClinicRecruiting
  • Eastern Shore Research InstituteRecruiting
  • Heart Center Research LLCRecruiting
  • Northern Arizona Healthcare Corporation Cardiovascular InstituteRecruiting
  • Scottsdale Healthcare at Shea - HonorHealthRecruiting
  • Pima Heart and Vascular Clinical ResearchRecruiting
  • John Muir Health and Cardiovascular InstituteRecruiting
  • VA Greater Los Angeles Healthcare SystemRecruiting
  • University of California Los AngelesRecruiting
  • University of California-IrvineRecruiting
  • University of Colorado HospitalRecruiting
  • Bridgeport HospitalRecruiting
  • Hartford HospitalRecruiting
  • Cardiology Associates of Fairfield County PCRecruiting
  • Excel Medical Clinical TrialsRecruiting
  • Clearwater Cardiovascular ConsultantsRecruiting
  • University of Florida at GainesvilleRecruiting
  • University of Florida at UF Health JacksonvilleRecruiting
  • AdventHealth OrlandoRecruiting
  • Cardiology Partners Clinical Research InstituteRecruiting
  • Baptist Health CareRecruiting
  • Ascension Sacred HeartRecruiting
  • Clearwater Cardiovascular ConsultantsRecruiting
  • Tampa Cardiovascular Interventions and ResearchRecruiting
  • Clinical Site Partners Orlando dba Flourish ResearchRecruiting
  • Saint Lukes Boise Medical CenterRecruiting
  • Jesse Brown Veterans Affairs Medical CenterRecruiting
  • Great Lakes Clinical Trials - RavenswoodRecruiting
  • Advocate Lutheran General HospitalRecruiting
  • Ascension Saint Vincent Heart CenterRecruiting
  • Reid Physician AssociatesRecruiting
  • University of Kansas HospitalRecruiting
  • Midwest Heart and Vascular SpecialistsRecruiting
  • UofL Health - Jewish HospitalRecruiting
  • Massachusetts General HospitalRecruiting
  • Henry Ford HospitalRecruiting
  • Healthy Heart CardiologyRecruiting
  • Sparrow Clinical Research InstituteRecruiting
  • McLaren Macomb Research ServicesRecruiting
  • McLaren Northern Michigan HospitalRecruiting
  • Rochester HillsRecruiting
  • Essentia Health Saint Marys Medical CenterRecruiting
  • Jackson HeartRecruiting
  • Cardiology Associates of North MississippiRecruiting
  • Saint Lukes Hospital of Kansas CityRecruiting
  • North Kansas City HospitalRecruiting
  • Advanced Heart Care LLCRecruiting
  • Hackensack University Medical CenterRecruiting
  • Saint Michaels Medical CenterRecruiting
  • South Shore University Hospital Northwell HealthRecruiting
  • New York Presbyterian-Weill Cornell Medical CenterRecruiting
  • Hudson Valley Cardiovascular Practice PCRecruiting
  • University of Rochester Medical CenterRecruiting
  • Richmond University Medical CenterRecruiting
  • University of North Carolina CardiologyRecruiting
  • Novant Health Heart and Vascular Institute Presbyterian Medical CenterRecruiting
  • Moses H Cone Memorial HospitalRecruiting
  • Aultman HospitalRecruiting
  • The Ohio State University Wexner Medical CenterRecruiting
  • Genesis Heart and Vascular InstituteRecruiting
  • Ascension Saint John BartlesvilleRecruiting
  • Ascension Saint John TulsaRecruiting
  • Wellspan Chambersburg HospitalRecruiting
  • Lancaster General Hospital/The Heart Group of LancasterRecruiting
  • Reading Hospital Tower HealthRecruiting
  • Rhode Island HospitalRecruiting
  • Kent HospitalRecruiting
  • Prisma Upstate and Midlands Greenville Hospital SystemRecruiting
  • Upstate CardiologyRecruiting
  • Turkey Creek Medical CenterRecruiting
  • Ascension Saint Thomas NashvilleRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Parkway Cardiology AssociatesRecruiting
  • Cardiovascular Research of Knoxville North Knoxville Medical CenterRecruiting
  • Ascension Texas CardiovascularRecruiting
  • Ascension Texas Cardiovascular KyleRecruiting
  • Bon Secours St Marys Hospital RichmondRecruiting
  • Chippenham HospitalRecruiting
  • Aurora Saint Lukes Medical CenterRecruiting
  • Instituto Cardiovascular de LinharesRecruiting
  • Hospital Ruy AzeredoRecruiting
  • Hospital Universitário Ciências Médicas de Belo HorizonteRecruiting
  • Hospital do Coracao de Pocos de Caldas CEC servicos medicosRecruiting
  • Pronto Socorro Cardiologico de Pernambuco PROCAPERecruiting
  • Instituto Atena de Pesquisa ClínicaRecruiting
  • Centro de Pesquisa Clínica Associação Hospitalar Moinhos de VentoRecruiting
  • Hospital de Clínicas de Porto AlegreRecruiting
  • Instituto de Cardiologia Fundação de Cardiologia ICFUCRecruiting
  • Santa Casa de Porto AlegreRecruiting
  • Hospital Mãe de DeusRecruiting
  • Hospital Beneficência PortuguesaRecruiting
  • C-MEP Centro Multidisciplinar de Ensino e PesquisaRecruiting
  • Instituto de Cardiologia de Santa CatarinaRecruiting
  • Centro de Pesquisa Clínica do CoracaoRecruiting
  • Hospital Universitario Sao Francisco na Providencia de DeusRecruiting
  • Instituto de Pesquisa Clínica de CampinasRecruiting
  • Irmandade da Santa Casa de Misericordia de MariliaRecruiting
  • Hospital Regional de Presidente PrudenteRecruiting
  • Instituto Dante PazanesseRecruiting
  • Instituto do coracao da Faculdade de Medicina da Universidade de Sao Paulo - InCorRecruiting
  • Hospital Israelita Albert EinsteinRecruiting
  • Alingsas LasarettRecruiting
  • Gavle SjukhusRecruiting
  • Lanssjukhuset RyhovRecruiting
  • Blekingesjukhuset KarlskronaRecruiting
  • Linkoping University HospitalRecruiting
  • Sunderby SjukhusRecruiting
  • Skane Universitetssjukhus i LundRecruiting
  • Molndals SjukhusRecruiting
  • Vrinnevisjukhuset, NorrkoepingRecruiting
  • Ostersunds sjukhusRecruiting
  • SodersjukhusetRecruiting
  • Sundsvalls SjukhusRecruiting
  • Akademiska Sjukhuset i UppsalaRecruiting
  • Vastmanlands Sjukhus VasterasRecruiting
  • Centrallasarettet VaxjoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Evolocumab + Routine Lipid Management

Routine Lipid Management

Arm Description

Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.

Participants will receive routine lipid management per standard of care (SoC).

Outcomes

Primary Outcome Measures

Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death

Secondary Outcome Measures

Percentage Change From Baseline in LDL-C
Percent LDL-C change from baseline to 12 weeks in a subset of approximately 300 randomly selected participants.
Percentage Change From Baseline in LDL-C
Percent LDL-C change from baseline to 52 weeks in a subset of approximately 300 randomly selected participants.
Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death
Time to the First Occurrence of the Composite of Myocardial Infarction, Ischemic Stroke, any Arterial Revascularization Procedure, and All-Cause Death
Total Myocardial Infarctions Events
Total Arterial Revascularization Procedures
Total Ischemia-driven Coronary Revascularization Procedures
Total Ischemic Strokes
Time to Cardiovascular Death
Time to All-Cause Death

Full Information

First Posted
March 9, 2022
Last Updated
October 18, 2023
Sponsor
Amgen
Collaborators
Colorado Prevention Center
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1. Study Identification

Unique Protocol Identification Number
NCT05284747
Brief Title
EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction
Acronym
EVOLVE-MI
Official Title
EVOLVE-MI: A Pragmatic Randomized Multicenter Trial of EVOLocumab Administered Very Early to Reduce the Risk of Cardiovascular Events in Patients Hospitalized With Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
June 18, 2027 (Anticipated)
Study Completion Date
June 18, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
Collaborators
Colorado Prevention Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the effectiveness of early treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction [NSTEMI] and ST-segment elevation myocardial infarction [STEMI]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Myocardial Infarction, Stroke, Coronary Revascularization
Keywords
Acute Myocardial Infarction, Cardiovascular Disease, Stroke, Coronary revascularization, Evolocumab, STEMI, NSTEMI, Heart Attack, Pragmatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Evolocumab + Routine Lipid Management
Arm Type
Experimental
Arm Description
Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.
Arm Title
Routine Lipid Management
Arm Type
Active Comparator
Arm Description
Participants will receive routine lipid management per standard of care (SoC).
Intervention Type
Drug
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
Repatha, AMG 145
Intervention Description
Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection.
Intervention Type
Drug
Intervention Name(s)
Routine Lipid Management
Intervention Description
Routine lipid management therapies will be administered at the discretion of the investigator per SoC.
Primary Outcome Measure Information:
Title
Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death
Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Secondary Outcome Measure Information:
Title
Percentage Change From Baseline in LDL-C
Description
Percent LDL-C change from baseline to 12 weeks in a subset of approximately 300 randomly selected participants.
Time Frame
From Baseline to Week 12
Title
Percentage Change From Baseline in LDL-C
Description
Percent LDL-C change from baseline to 52 weeks in a subset of approximately 300 randomly selected participants.
Time Frame
From Baseline to Week 52
Title
Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death
Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Title
Time to the First Occurrence of the Composite of Myocardial Infarction, Ischemic Stroke, any Arterial Revascularization Procedure, and All-Cause Death
Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Title
Total Myocardial Infarctions Events
Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Title
Total Arterial Revascularization Procedures
Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Title
Total Ischemia-driven Coronary Revascularization Procedures
Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Title
Total Ischemic Strokes
Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Title
Time to Cardiovascular Death
Time Frame
From Baseline to End of Study (Approximately 3.5 Years)
Title
Time to All-Cause Death
Time Frame
From Baseline to End of Study (Approximately 3.5 Years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 18 years Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease Exclusion Criteria: Participants requiring invasive hemodynamic and/or vasopressor/inotropic support at the time of screening Participants with elevated biomarkers of myocardial injury due to secondary/nonatherosclerotic etiology (eg, sepsis, atrial fibrillation, vasospasm, decompensated heart failure, uncontrolled hypertension, stress induced cardiomyopathy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Uab Heart and Vascular Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Eastern Shore Research Institute
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Individual Site Status
Recruiting
Facility Name
Heart Center Research LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801-4317
Country
United States
Individual Site Status
Recruiting
Facility Name
Northern Arizona Healthcare Corporation Cardiovascular Institute
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
Individual Site Status
Recruiting
Facility Name
Scottsdale Healthcare at Shea - HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Name
Pima Heart and Vascular Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Name
John Muir Health and Cardiovascular Institute
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Individual Site Status
Recruiting
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California-Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Individual Site Status
Recruiting
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Recruiting
Facility Name
Cardiology Associates of Fairfield County PC
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Name
Excel Medical Clinical Trials
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Individual Site Status
Recruiting
Facility Name
Clearwater Cardiovascular Consultants
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida at Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida at UF Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Name
Cardiology Partners Clinical Research Institute
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Health Care
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension Sacred Heart
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Individual Site Status
Recruiting
Facility Name
Clearwater Cardiovascular Consultants
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Individual Site Status
Recruiting
Facility Name
Tampa Cardiovascular Interventions and Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site Partners Orlando dba Flourish Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Lukes Boise Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Individual Site Status
Recruiting
Facility Name
Jesse Brown Veterans Affairs Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Great Lakes Clinical Trials - Ravenswood
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension Saint Vincent Heart Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Individual Site Status
Recruiting
Facility Name
Reid Physician Associates
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Heart and Vascular Specialists
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Recruiting
Facility Name
UofL Health - Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Healthy Heart Cardiology
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Individual Site Status
Recruiting
Facility Name
McLaren Macomb Research Services
City
Mount Clemens
State/Province
Michigan
ZIP/Postal Code
48043
Country
United States
Individual Site Status
Recruiting
Facility Name
McLaren Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Individual Site Status
Recruiting
Facility Name
Rochester Hills
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Individual Site Status
Recruiting
Facility Name
Essentia Health Saint Marys Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Individual Site Status
Recruiting
Facility Name
Jackson Heart
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Name
Cardiology Associates of North Mississippi
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Lukes Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Name
North Kansas City Hospital
City
North Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Heart Care LLC
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Michaels Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Individual Site Status
Recruiting
Facility Name
South Shore University Hospital Northwell Health
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Presbyterian-Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Hudson Valley Cardiovascular Practice PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
Richmond University Medical Center
City
Staten Island
State/Province
New York
ZIP/Postal Code
10310
Country
United States
Individual Site Status
Recruiting
Facility Name
University of North Carolina Cardiology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health Heart and Vascular Institute Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Moses H Cone Memorial Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Individual Site Status
Recruiting
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Genesis Heart and Vascular Institute
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension Saint John Bartlesville
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension Saint John Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Name
Wellspan Chambersburg Hospital
City
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
Country
United States
Individual Site Status
Recruiting
Facility Name
Lancaster General Hospital/The Heart Group of Lancaster
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17603
Country
United States
Individual Site Status
Recruiting
Facility Name
Reading Hospital Tower Health
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Individual Site Status
Recruiting
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Name
Kent Hospital
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Individual Site Status
Recruiting
Facility Name
Prisma Upstate and Midlands Greenville Hospital System
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting
Facility Name
Upstate Cardiology
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
Turkey Creek Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension Saint Thomas Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-8802
Country
United States
Individual Site Status
Recruiting
Facility Name
Parkway Cardiology Associates
City
Oak Ridge
State/Province
Tennessee
ZIP/Postal Code
37830
Country
United States
Individual Site Status
Recruiting
Facility Name
Cardiovascular Research of Knoxville North Knoxville Medical Center
City
Powell
State/Province
Tennessee
ZIP/Postal Code
37849
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension Texas Cardiovascular
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension Texas Cardiovascular Kyle
City
Kyle
State/Province
Texas
ZIP/Postal Code
78640
Country
United States
Individual Site Status
Recruiting
Facility Name
Bon Secours St Marys Hospital Richmond
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Individual Site Status
Recruiting
Facility Name
Chippenham Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Individual Site Status
Recruiting
Facility Name
Aurora Saint Lukes Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Recruiting
Facility Name
Instituto Cardiovascular de Linhares
City
Linhares
State/Province
Espírito Santo
ZIP/Postal Code
29900010
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Ruy Azeredo
City
Ipiranga Goiânia
State/Province
Goiás
ZIP/Postal Code
74453-200
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Universitário Ciências Médicas de Belo Horizonte
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30140-073
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital do Coracao de Pocos de Caldas CEC servicos medicos
City
Pocos de Caldas
State/Province
Minas Gerais
ZIP/Postal Code
37706-106
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Pronto Socorro Cardiologico de Pernambuco PROCAPE
City
Casa Forte
State/Province
Pernambuco
ZIP/Postal Code
52061-540
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Atena de Pesquisa Clínica
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59020-500
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro de Pesquisa Clínica Associação Hospitalar Moinhos de Vento
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto de Cardiologia Fundação de Cardiologia ICFUC
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90620-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Santa Casa de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90620-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Mãe de Deus
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90840-440
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Beneficência Portuguesa
City
São Paulo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
01323-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
C-MEP Centro Multidisciplinar de Ensino e Pesquisa
City
Joinville
State/Province
Santa Catarina
ZIP/Postal Code
89204-250
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto de Cardiologia de Santa Catarina
City
Praia Comprida, Sao Jose
State/Province
Santa Catarina
ZIP/Postal Code
88103-450
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro de Pesquisa Clínica do Coracao
City
Aracaju
State/Province
Sergipe
ZIP/Postal Code
49055-530
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Sao Francisco na Providencia de Deus
City
Braganca Paulista
State/Province
São Paulo
ZIP/Postal Code
12916542
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto de Pesquisa Clínica de Campinas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13060-080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Irmandade da Santa Casa de Misericordia de Marilia
City
Marilia
State/Province
São Paulo
ZIP/Postal Code
90840-440
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Regional de Presidente Prudente
City
Presidente Prudente
State/Province
São Paulo
ZIP/Postal Code
19050-680
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Dante Pazanesse
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
04012-909
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto do coracao da Faculdade de Medicina da Universidade de Sao Paulo - InCor
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
ZIP/Postal Code
05652-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Alingsas Lasarett
City
Alingsas
ZIP/Postal Code
441 33
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Gavle Sjukhus
City
Gavle
ZIP/Postal Code
801 88
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Lanssjukhuset Ryhov
City
Jonkoping
ZIP/Postal Code
553 05
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Blekingesjukhuset Karlskrona
City
Karlskrona
ZIP/Postal Code
371 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Linkoping University Hospital
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Sunderby Sjukhus
City
Lulea
ZIP/Postal Code
971 80
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Skane Universitetssjukhus i Lund
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Molndals Sjukhus
City
Molndahl
ZIP/Postal Code
431 80
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Vrinnevisjukhuset, Norrkoeping
City
Norrkoeping
ZIP/Postal Code
601 82
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Ostersunds sjukhus
City
Ostersund
ZIP/Postal Code
831 83
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Sodersjukhuset
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Sundsvalls Sjukhus
City
Sundsvall
ZIP/Postal Code
851 86
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Akademiska Sjukhuset i Uppsala
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Vastmanlands Sjukhus Vasteras
City
Vasteras
ZIP/Postal Code
721 89
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Centrallasarettet Vaxjo
City
Vaxjo
ZIP/Postal Code
351 85
Country
Sweden
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction

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