Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005272-19 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Colorado Prevention Center | OTHER |
Not provided
Not provided
Not provided
Not provided
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]).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evolocumab + Routine Lipid Management | Experimental | Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management. |
|
| Routine Lipid Management | Active Comparator | Participants will receive routine lipid management per standard of care (SoC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab | Drug | Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death | From Baseline to End of Study (Approximately 3.5 Years) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline to Week 12 |
| Percentage Change From Baseline in LDL-C |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Eastern Shore Research Institute |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Routine Lipid Management | Drug | Routine lipid management therapies will be administered at the discretion of the investigator per SoC. |
|
Percent LDL-C change from baseline to 52 weeks in a subset of approximately 300 randomly selected participants.
| From Baseline to Week 52 |
| Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death | From Baseline to End of Study (Approximately 3.5 Years) |
| Time to the First Occurrence of the Composite of Myocardial Infarction, Ischemic Stroke, any Arterial Revascularization Procedure, and All-Cause Death | From Baseline to End of Study (Approximately 3.5 Years) |
| Total Myocardial Infarctions Events | From Baseline to End of Study (Approximately 3.5 Years) |
| Total Arterial Revascularization Procedures | From Baseline to End of Study (Approximately 3.5 Years) |
| Total Ischemia-driven Coronary Revascularization Procedures | From Baseline to End of Study (Approximately 3.5 Years) |
| Total Ischemic Strokes | From Baseline to End of Study (Approximately 3.5 Years) |
| Time to Cardiovascular Death | From Baseline to End of Study (Approximately 3.5 Years) |
| Time to All-Cause Death | From Baseline to End of Study (Approximately 3.5 Years) |
| Fairhope |
| Alabama |
| 36532 |
| United States |
| Heart Center Research LLC | Huntsville | Alabama | 35801-4317 | United States |
| Northern Arizona Healthcare Corporation Cardiovascular Institute | Flagstaff | Arizona | 86001 | United States |
| Scottsdale Healthcare at Shea - HonorHealth | Scottsdale | Arizona | 85258 | United States |
| Pima Heart and Vascular Clinical Research | Tucson | Arizona | 85719 | United States |
| John Muir Health and Cardiovascular Institute | Concord | California | 94520 | United States |
| VA Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| University of California-Irvine | Orange | California | 92868 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States |
| Hartford Hospital | Hartford | Connecticut | 06106 | United States |
| Cardiology Associates of Fairfield County PC | Stamford | Connecticut | 06905 | United States |
| Excel Medical Clinical Trials | Boca Raton | Florida | 33434 | United States |
| Clearwater Cardiovascular Consultants | Clearwater | Florida | 33756 | United States |
| University of Florida at Gainesville | Gainesville | Florida | 32610 | United States |
| University of Florida and Shands Hospital | Jacksonville | Florida | 32209 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Cardiology Partners Clinical Research Institute | Palm Beach Gardens | Florida | 33410 | United States |
| Baptist Health Care | Pensacola | Florida | 32501 | United States |
| Ascension Sacred Heart | Pensacola | Florida | 32504 | United States |
| Clearwater Cardiovascular Consultants | Safety Harbor | Florida | 34695 | United States |
| Tampa Cardiovascular Interventions and Research | Tampa | Florida | 33614 | United States |
| Clinical Site Partners Orlando dba Flourish Research | Winter Park | Florida | 32789 | United States |
| Saint Lukes Boise Medical Center | Boise | Idaho | 83712 | United States |
| Jesse Brown Veterans Affairs Medical Center | Chicago | Illinois | 60612 | United States |
| Great Lakes Clinical Trials - Ravenswood | Chicago | Illinois | 60640 | United States |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | United States |
| Ascension Saint Vincent Heart Center | Indianapolis | Indiana | 46290 | United States |
| Reid Physician Associates | Richmond | Indiana | 47374 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| Midwest Heart and Vascular Specialists | Overland Park | Kansas | 66211 | United States |
| University of Louisville Health - Jewish Hospital | Louisville | Kentucky | 40202 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Healthy Heart Cardiology | Grand Rapids | Michigan | 49546 | United States |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | United States |
| McLaren Macomb Research Services | Mount Clemens | Michigan | 48043 | United States |
| McLaren Northern Michigan Hospital | Petoskey | Michigan | 49770 | United States |
| Advanced Cardiology Associates | Rochester Hills | Michigan | 48307 | United States |
| Essentia Health Saint Marys Medical Center | Duluth | Minnesota | 55805 | United States |
| Jackson Heart | Jackson | Mississippi | 39216 | United States |
| Cardiology Associates of North Mississippi | Tupelo | Mississippi | 38801 | United States |
| Saint Lukes Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| North Kansas City Hospital | North Kansas City | Missouri | 64116 | United States |
| Advanced Heart Care LLC | Bridgewater | New Jersey | 08807 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Saint Michaels Medical Center | Newark | New Jersey | 07102 | United States |
| South Shore University Hospital Northwell Health | Bay Shore | New York | 11706 | United States |
| New York Presbyterian-Weill Cornell Medical Center | New York | New York | 10065 | United States |
| Hudson Valley Cardiovascular Practice PC | Poughkeepsie | New York | 12601 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Richmond University Medical Center | Staten Island | New York | 10310 | United States |
| Stony Brook Medicine | Stony Brook | New York | 11794 | United States |
| Montefiore Medical Center | The Bronx | New York | 10580 | United States |
| University of North Carolina Cardiology | Chapel Hill | North Carolina | 27599 | United States |
| Novant Health Heart and Vascular Institute Presbyterian Medical Center | Charlotte | North Carolina | 28204 | United States |
| Moses H Cone Memorial Hospital | Greensboro | North Carolina | 27401 | United States |
| Aultman Hospital | Canton | Ohio | 44710 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Genesis Healthcare System | Zanesville | Ohio | 43701 | United States |
| Ascension Saint John Bartlesville | Tulsa | Oklahoma | 74104 | United States |
| Ascension Saint John Tulsa | Tulsa | Oklahoma | 74104 | United States |
| Wellspan Chambersburg Hospital | Chambersburg | Pennsylvania | 17201 | United States |
| Lancaster General Hospital/The Heart Group of Lancaster | Lancaster | Pennsylvania | 17603 | United States |
| Reading Hospital Tower Health | West Reading | Pennsylvania | 19611 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Kent Hospital | Warwick | Rhode Island | 02886 | United States |
| Prisma Upstate and Midlands Greenville Hospital System | Columbia | South Carolina | 29203 | United States |
| Upstate Cardiology | Greenville | South Carolina | 29607 | United States |
| Tennova Healthcare-Turkey Creek Medical Center | Knoxville | Tennessee | 37934 | United States |
| Ascension Saint Thomas Nashville | Nashville | Tennessee | 37205 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-8802 | United States |
| Parkway Cardiology Associates | Oak Ridge | Tennessee | 37830 | United States |
| Cardiovascular Research of Knoxville North Knoxville Medical Center | Powell | Tennessee | 37849 | United States |
| Ascension Texas Cardiovascular | Austin | Texas | 78705 | United States |
| Ascension Texas Cardiovascular Kyle | Kyle | Texas | 78640 | United States |
| Bon Secours St Marys Hospital Richmond | Midlothian | Virginia | 23114 | United States |
| Chippenham Hospital | Richmond | Virginia | 23225 | United States |
| Aurora Saint Lukes Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Clínica Silvestre Sante | Rio Branco | Acre | 69900785 | Brazil |
| Instituto Cardiovascular de Linhares | Linhares | Espírito Santo | 29900010 | Brazil |
| Hospital Ruy Azeredo | Ipiranga Goiânia | Goiás | 74453-200 | Brazil |
| Hospital Universitario Sao Francisco na Providencia de Deus | Ipiranga Goiânia | Goiás | 74453-200 | Brazil |
| Hospital Madre Teresa | Belo Horizonte | Minas Gerais | 30140-073 | Brazil |
| Hospital Universitário Ciências Médicas de Belo Horizonte | Belo Horizonte | Minas Gerais | 30140-073 | Brazil |
| Hospital do Coracao de Pocos de Caldas CEC servicos medicos | Poços de Caldas | Minas Gerais | 37706-106 | Brazil |
| Ps Cardiologico de PE - Procape | Casa Forte | Pernambuco | 52061-540 | Brazil |
| Instituto Atena de Pesquisa Clínica | Natal | Rio Grande do Norte | 59020-500 | Brazil |
| Centro de Pesquisa Clínica Associação Hospitalar Moinhos de Vento | Porto Alegre | Rio Grande do Sul | 90035-001 | Brazil |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Instituto de Cardiologia do Rio Grande do Sul | Porto Alegre | Rio Grande do Sul | 90620-001 | Brazil |
| Santa Casa de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90620-001 | Brazil |
| Hospital Mãe de Deus | Porto Alegre | Rio Grande do Sul | 90840-440 | Brazil |
| Hospital Beneficência Portuguesa | São Paulo | Rio Grande do Sul | 01323-900 | Brazil |
| Cmep-Centro Multidisciplinar Ensino e Pesq | Joinville | Santa Catarina | 89204-250 | Brazil |
| Instituto de Cardiologia de Santa Catarina | Praia Comprida, Sao Jose | Santa Catarina | 88103-450 | Brazil |
| Centro de Pesquisa Clinica do Coracao | Aracaju | Sergipe | 49055-530 | Brazil |
| Instituto de Pesquisa Clínica de Campinas | Campinas | São Paulo | 13060-080 | Brazil |
| Irmandade da Santa Casa de Misericordia de Marilia | Marília | São Paulo | 90840-440 | Brazil |
| Hospital Regional de Presidente Prudente | Presidente Prudente | São Paulo | 19050-680 | Brazil |
| Instituto Dante Pazanesse | São Paulo | São Paulo | 04012-909 | Brazil |
| Instituto do coracao da Faculdade de Medicina da Universidade de Sao Paulo - InCor | São Paulo | 05403-000 | Brazil |
| Hospital Israelita Albert Einstein | São Paulo | 05652-900 | Brazil |
| Alingsas Lasarett | Alingsås | 441 33 | Sweden |
| Gavle Sjukhus | Gävle | 801 88 | Sweden |
| Lanssjukhuset Ryhov | Jönköping | 553 05 | Sweden |
| Blekingesjukhuset Karlskrona | Karlskrona | 371 85 | Sweden |
| Linkoping University Hospital | Linköping | 581 85 | Sweden |
| Sunderby Sjukhus | Luleå | 971 80 | Sweden |
| Skane Universitetssjukhus i Lund | Lund | 221 85 | Sweden |
| Molndals Sjukhus | Molndahl | 431 80 | Sweden |
| Vrinnevisjukhuset, Norrkoeping | Norrköping | 601 82 | Sweden |
| Ostersunds sjukhus | Östersund | 831 83 | Sweden |
| Sodersjukhuset | Stockholm | 118 83 | Sweden |
| Sundsvalls Sjukhus | Sundsvall | 851 86 | Sweden |
| Akademiska Sjukhuset i Uppsala | Uppsala | 751 85 | Sweden |
| Centrallasarettet Vaxjo | Vaxjo | 351 85 | Sweden |
| Vastmanlands Sjukhus Vasteras | Västerås | 721 89 | Sweden |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| D020521 | Stroke |
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C577155 | evolocumab |
Not provided
Not provided
Not provided