Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03872401 |
Recruitment Status :
Recruiting
First Posted : March 13, 2019
Last Update Posted : December 7, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Heart Disease (CHD) | Drug: Evolocumab Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 12000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke |
Actual Study Start Date : | June 11, 2019 |
Estimated Primary Completion Date : | June 20, 2025 |
Estimated Study Completion Date : | June 20, 2025 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Participants will receive placebo subcutaneous injection once every 2 weeks (Q2W) for a minimum of 4 years.
|
Drug: Placebo
Administered subcutaneously using an autoinjector pen. |
Experimental: Evolocumab 140 mg Q2W
Participants will receive 140 mg evolocumab by subcutaneous injection once every 2 weeks for a minimum of 4 years.
|
Drug: Evolocumab
Administered subcutaneously using an autoinjector pen.
Other Names:
|
- Time to Coronary Heart Disease Death, Myocardial Infarction, or Ischemic Stroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]Time to coronary heart disease (CHD) death, myocardial infarction (MI), or ischemic stroke, whichever occurs first.
- Time to Coronary Heart Disease Death, Myocardial Infarction, Ischemic Stroke, or Any Ischemia-driven Arterial Sroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]Time to CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurs first.
- Time to MI, Ischemic Stroke, or Any Ischemia-driven Arterial Revascularization [ Time Frame: From randomization; for approximately a median of 4.5 years ]
- Time to CHD Death, MI, or Any Ischemia-driven Arterial Revascularization [ Time Frame: From randomization; for approximately a median of 4.5 years ]
- Time to Cardiovascular Death, MI, or Stroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]
- Time to Myocardial Infarction [ Time Frame: From randomization; for approximately a median of 4.5 years ]
- Time to Any Ischemia-driven Arterial Revascularization [ Time Frame: From randomization; for approximately a median of 4.5 years ]
- Time to CHD Death [ Time Frame: From randomization; for approximately a median of 4.5 years ]
- Time to Cardiovascular Death [ Time Frame: From randomization; for approximately a median of 4.5 years ]
- Time to All Cause of Death [ Time Frame: From randomization; for approximately a median of 4.5 years ]
- Time to Ischemic Stroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Age: Adult subjects ≥ 50 (men) or ≥ 55 (women) to ˂ 80 years of age (either sex) and meeting lipid criteria
- Low-density lipoprotein cholesterol (LDL-C) ≥ 90 mg/dL (≥ 2.3 mmol/L) or non-high-density lipoprotein cholesterol (non-HDL) ≥ 120 mg/dL (≥ 3.1 mmol/L), or apolipoprotein B ≥ 80 mg/dL (≥ 1.56 µmol/L)
-
Evidence of at least one of the following at screening (without prior myocardial infarction or stroke):
A. Significant coronary artery disease (CAD) B. Significant atherosclerotic cerebrovascular disease C. Significant peripheral arterial disease D. Diabetes mellitus
- At least 1 high-risk feature
Exclusion criteria
- MI or stroke prior to randomization
- Coronary artery bypass grafting (CABG) ˂ 3 months prior to screening
- Estimated glomerular filtration rate (eGFR) ˂ 15 mL/min/1.73 m²
- Uncontrolled or recurrent ventricular tachycardia in the absence of an implantable-cardioverter defibrillator.
- Atrial fibrillation or atrial flutter not on anticoagulation therapy (vitamin K antagonist, heparin, low molecular weight heparin, fondaparinux,or non-Vitamin K antagonist oral anticoagulant)
- Triglycerides ≥ 500 mg/dL (5.7 mmol/L) measured up to 3 months prior to screening. The most recent results must be used.
- Last measured left-ventricular ejection fraction ˂ 30% or New York Heart Association (NYHA) Functional Class III/IV
- Planned arterial revascularization

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872401
Contact: Amgen Call Center | 866-572-6436 | medinfo@amgen.com |


United States, Alabama | |
Research Site | Recruiting |
Huntsville, Alabama, United States, 35801 | |
Research Site | Recruiting |
Mobile, Alabama, United States, 36608 | |
United States, Arkansas | |
Research Site | Recruiting |
Little Rock, Arkansas, United States, 72205 | |
United States, California | |
Research Site | Recruiting |
Beverly Hills, California, United States, 90210 | |
Research Site | Recruiting |
Beverly Hills, California, United States, 90211 | |
Research Site | Recruiting |
Riverside, California, United States, 92506 | |
Research Site | Recruiting |
Roseville, California, United States, 95661 | |
Research Site | Recruiting |
Sacramento, California, United States, 95823 | |
Research Site | Recruiting |
Torrance, California, United States, 90502 | |
United States, Colorado | |
Research Site | Recruiting |
Colorado Springs, Colorado, United States, 80906 | |
Research Site | Recruiting |
Colorado Springs, Colorado, United States, 80909 | |
Research Site | Recruiting |
Golden, Colorado, United States, 80401 | |
Research Site | Recruiting |
Littleton, Colorado, United States, 80120 | |
United States, Connecticut | |
Research Site | Recruiting |
Stamford, Connecticut, United States, 06905 | |
United States, Florida | |
Research Site | Recruiting |
Boca Raton, Florida, United States, 33434 | |
Research Site | Recruiting |
Brandon, Florida, United States, 33511 | |
Research Site | Recruiting |
Crystal River, Florida, United States, 34429 | |
Research Site | Recruiting |
Daytona Beach, Florida, United States, 32114 | |
Research Site | Recruiting |
Daytona Beach, Florida, United States, 32117 | |
Research Site | Recruiting |
Delray Beach, Florida, United States, 33446 | |
Research Site | Recruiting |
Green Cove Springs, Florida, United States, 32043 | |
Research Site | Recruiting |
Hollywood, Florida, United States, 33021 | |
Research Site | Recruiting |
Jacksonville, Florida, United States, 32209 | |
Research Site | Recruiting |
Jacksonville, Florida, United States, 32216 | |
Research Site | Recruiting |
Miami, Florida, United States, 33155 | |
Research Site | Recruiting |
Miami, Florida, United States, 33173 | |
Research Site | Recruiting |
Ocala, Florida, United States, 34471 | |
Research Site | Recruiting |
Sarasota, Florida, United States, 34239 | |
Research Site | Recruiting |
Winter Park, Florida, United States, 32792 | |
United States, Georgia | |
Research Site | Recruiting |
Cumming, Georgia, United States, 30041 | |
United States, Idaho | |
Research Site | Recruiting |
Coeur d'Alene, Idaho, United States, 83814 | |
United States, Illinois | |
Research Site | Recruiting |
Arlington Heights, Illinois, United States, 60005 | |
United States, Indiana | |
Research Site | Recruiting |
Evansville, Indiana, United States, 47714 | |
Research Site | Recruiting |
Michigan City, Indiana, United States, 46360 | |
United States, Iowa | |
Research Site | Recruiting |
Davenport, Iowa, United States, 52803 | |
Research Site | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Research Site | Recruiting |
West Des Moines, Iowa, United States, 50266 | |
United States, Kentucky | |
Research Site | Recruiting |
Covington, Kentucky, United States, 41011 | |
United States, Louisiana | |
Research Site | Recruiting |
Eunice, Louisiana, United States, 70535 | |
Research Site | Recruiting |
Hammond, Louisiana, United States, 70403 | |
Research Site | Recruiting |
Slidell, Louisiana, United States, 70458 | |
United States, Maine | |
Research Site | Recruiting |
Bangor, Maine, United States, 04401 | |
United States, Maryland | |
Research Site | Recruiting |
Baltimore, Maryland, United States, 21229 | |
Research Site | Recruiting |
Salisbury, Maryland, United States, 21804 | |
United States, Massachusetts | |
Research Site | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Research Site | Recruiting |
Great Barrington, Massachusetts, United States, 01230 | |
Research Site | Recruiting |
Natick, Massachusetts, United States, 01760 | |
United States, Michigan | |
Research Site | Recruiting |
Flint, Michigan, United States, 48504 | |
Research Site | Recruiting |
Grand Rapids, Michigan, United States, 49546 | |
United States, Minnesota | |
Research Site | Recruiting |
Duluth, Minnesota, United States, 55805 | |
Research Site | Recruiting |
Minneapolis, Minnesota, United States, 55407 | |
Research Site | Recruiting |
Saint Cloud, Minnesota, United States, 56303 | |
Research Site | Recruiting |
Saint Paul, Minnesota, United States, 55102 | |
United States, Missouri | |
Research Site | Recruiting |
Saint Louis, Missouri, United States, 63141 | |
United States, Nebraska | |
Research Site | Recruiting |
Lincoln, Nebraska, United States, 68506 | |
United States, Nevada | |
Research Site | Recruiting |
Las Vegas, Nevada, United States, 89148 | |
United States, New Jersey | |
Research Site | Recruiting |
Voorhees, New Jersey, United States, 08043 | |
United States, New York | |
Research Site | Recruiting |
Brooklyn, New York, United States, 11206 | |
Research Site | Recruiting |
Buffalo, New York, United States, 14215 | |
Research Site | Recruiting |
Kingston, New York, United States, 12401 | |
Research Site | Recruiting |
New Hyde Park, New York, United States, 11042 | |
Research Site | Recruiting |
New York, New York, United States, 10022 | |
Research Site | Recruiting |
Southampton, New York, United States, 11968 | |
United States, North Carolina | |
Research Site | Recruiting |
Asheville, North Carolina, United States, 28803 | |
Research Site | Recruiting |
Greensboro, North Carolina, United States, 27401 | |
Research Site | Recruiting |
Winston-Salem, North Carolina, United States, 27157 | |
United States, North Dakota | |
Research Site | Recruiting |
Fargo, North Dakota, United States, 58104 | |
United States, Ohio | |
Research Site | Recruiting |
Cincinnati, Ohio, United States, 45219 | |
Research Site | Recruiting |
Elyria, Ohio, United States, 44035 | |
Research Site | Recruiting |
Marion, Ohio, United States, 43302 | |
Research Site | Recruiting |
Sandusky, Ohio, United States, 44870 | |
United States, Pennsylvania | |
Research Site | Recruiting |
Camp Hill, Pennsylvania, United States, 17011 | |
Research Site | Recruiting |
Doylestown, Pennsylvania, United States, 18901 | |
Research Site | Recruiting |
Jersey Shore, Pennsylvania, United States, 17740 | |
Research Site | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Rhode Island | |
Research Site | Recruiting |
East Greenwich, Rhode Island, United States, 02818 | |
United States, South Carolina | |
Research Site | Recruiting |
Charleston, South Carolina, United States, 29412 | |
Research Site | Recruiting |
Greer, South Carolina, United States, 29651 | |
Research Site | Recruiting |
Little River, South Carolina, United States, 29566 | |
Research Site | Recruiting |
Murrells Inlet, South Carolina, United States, 29576 | |
Research Site | Recruiting |
Summerville, South Carolina, United States, 29485 | |
United States, South Dakota | |
Research Site | Recruiting |
Rapid City, South Dakota, United States, 57701 | |
United States, Tennessee | |
Research Site | Recruiting |
Oak Ridge, Tennessee, United States, 37830 | |
United States, Texas | |
Research Site | Recruiting |
Dallas, Texas, United States, 75235 | |
Research Site | Recruiting |
Kingwood, Texas, United States, 77339 | |
Research Site | Recruiting |
McKinney, Texas, United States, 75071 | |
Research Site | Recruiting |
Mesquite, Texas, United States, 75149 | |
Research Site | Recruiting |
Odessa, Texas, United States, 79761 | |
Research Site | Recruiting |
San Antonio, Texas, United States, 78201 | |
Research Site | Recruiting |
San Antonio, Texas, United States, 78229 | |
Research Site | Recruiting |
Tomball, Texas, United States, 77375 | |
United States, Utah | |
Research Site | Recruiting |
Farmington, Utah, United States, 84025 | |
United States, Virginia | |
Research Site | Recruiting |
Suffolk, Virginia, United States, 23435 | |
Research Site | Recruiting |
Winchester, Virginia, United States, 22601 | |
Argentina | |
Research Site | Recruiting |
Caba, Buenos Aires, Argentina, C1023AAB | |
Research Site | Recruiting |
Caba, Buenos Aires, Argentina, C1027AAP | |
Research Site | Recruiting |
Caba, Buenos Aires, Argentina, C1119ACN | |
Research Site | Recruiting |
Caba, Buenos Aires, Argentina, C1406BOA | |
Research Site | Recruiting |
Caba, Buenos Aires, Argentina, C1407GTN | |
Research Site | Recruiting |
Caba, Buenos Aires, Argentina, C1425AGC | |
Research Site | Recruiting |
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1430 | |
Research Site | Recruiting |
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1012AAR | |
Research Site | Recruiting |
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP | |
Research Site | Recruiting |
Mar del Plata, Buenos Aires, Argentina, B7600FZN | |
Research Site | Recruiting |
Moron, Buenos Aires, Argentina, B1708EPE | |
Research Site | Recruiting |
San Nicolas, Buenos Aires, Argentina, B2900DMH | |
Research Site | Recruiting |
Zarate, Buenos Aires, Argentina, B2800 | |
Research Site | Recruiting |
Santa Rosa, La Pampa, Argentina, 6300 | |
Research Site | Recruiting |
Rosario, Santa Fe, Argentina, 2000 | |
Research Site | Recruiting |
San Miguel de Tucuman, Tucuman, Argentina, 4000 | |
Research Site | Recruiting |
Corrientes, Argentina, W3400AMZ | |
Research Site | Recruiting |
Salta, Argentina, A4400ANW | |
Research Site | Recruiting |
San Juan, Argentina, J5400ARW | |
Research Site | Recruiting |
San Luis, Argentina, D5702JRS | |
Australia, Australian Capital Territory | |
Research Site | Recruiting |
Garran, Australian Capital Territory, Australia, 2605 | |
Australia, New South Wales | |
Research Site | Recruiting |
Camperdown, New South Wales, Australia, 2050 | |
Australia, Queensland | |
Research Site | Recruiting |
Auchenflower, Queensland, Australia, 4066 | |
Research Site | Recruiting |
Bundaberg, Queensland, Australia, 4670 | |
Research Site | Recruiting |
Milton, Queensland, Australia, 4064 | |
Australia, South Australia | |
Research Site | Recruiting |
Ashford, South Australia, Australia, 5035 | |
Research Site | Recruiting |
Fullarton, South Australia, Australia, 5063 | |
Research Site | Recruiting |
Leabrook, South Australia, Australia, 5068 | |
Australia, Victoria | |
Research Site | Recruiting |
Clayton, Victoria, Australia, 3168 | |
Research Site | Recruiting |
Epping, Victoria, Australia, 3076 | |
Research Site | Recruiting |
Geelong, Victoria, Australia, 3220 | |
Australia, Western Australia | |
Research Site | Recruiting |
Joondalup, Western Australia, Australia, 5068 | |
Australia | |
Research Site | Recruiting |
Woolloongabba, Australia, 4102 | |
Bulgaria | |
Research Site | Recruiting |
Haskovo, Bulgaria, 6300 | |
Research Site | Recruiting |
Pleven, Bulgaria, 5800 | |
Research Site | Recruiting |
Plovdiv, Bulgaria, 4002 | |
Research Site | Recruiting |
Plovdiv, Bulgaria, 4003 | |
Research Site | Recruiting |
Sofia, Bulgaria, 1202 | |
Research Site | Recruiting |
Sofia, Bulgaria, 1233 | |
Research Site | Recruiting |
Sofia, Bulgaria, 1407 | |
Research Site | Recruiting |
Sofia, Bulgaria, 1527 | |
Research Site | Recruiting |
Sofia, Bulgaria, 1606 | |
Research Site | Recruiting |
Sofia, Bulgaria, 1680 | |
Research Site | Recruiting |
Stara Zagora, Bulgaria, 6003 | |
Research Site | Recruiting |
Veliko Tarnovo, Bulgaria, 5002 | |
Canada, British Columbia | |
Research Site | Recruiting |
Surrey, British Columbia, Canada, V3V 1Z2 | |
Research Site | Completed |
Vancouver, British Columbia, Canada, V5Y 3W2 | |
Canada, Manitoba | |
Research Site | Recruiting |
Winnipeg, Manitoba, Canada, R3C 0N2 | |
Canada, New Brunswick | |
Research Site | Recruiting |
Moncton, New Brunswick, Canada, E1G 1A7 | |
Canada, Newfoundland and Labrador | |
Research Site | Recruiting |
Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7 | |
Canada, Nova Scotia | |
Research Site | Recruiting |
Halifax, Nova Scotia, Canada, B3H 3A7 | |
Canada, Ontario | |
Research Site | Recruiting |
Ajax, Ontario, Canada, L1Z 0B1 | |
Research Site | Recruiting |
Barrie, Ontario, Canada, L4N 7L3 | |
Research Site | Recruiting |
Brampton, Ontario, Canada, L6S 0C6 | |
Research Site | Recruiting |
Brampton, Ontario, Canada, L6Z 4N5 | |
Research Site | Recruiting |
Concord, Ontario, Canada, L4K 4M2 | |
Research Site | Recruiting |
Etobicoke, Ontario, Canada, M9R 4E1 | |
Research Site | Recruiting |
London, Ontario, Canada, N6G 2M1 | |
Research Site | Recruiting |
Markham, Ontario, Canada, L3P 7P2 | |
Research Site | Recruiting |
Nepean, Ontario, Canada, K2J 0V2 | |
Research Site | Recruiting |
Newmarket, Ontario, Canada, L3Y 5G8 | |
Research Site | Recruiting |
Oakville, Ontario, Canada, L6K 3W7 | |
Research Site | Recruiting |
Oshawa, Ontario, Canada, L1J 2K1 | |
Research Site | Recruiting |
Peterborough, Ontario, Canada, K9J 0B2 | |
Research Site | Recruiting |
Sarnia, Ontario, Canada, N7T 4X3 | |
Research Site | Recruiting |
Scarborough, Ontario, Canada, M1B 4Z8 | |
Research Site | Recruiting |
Toronto, Ontario, Canada, M6B 3H7 | |
Canada, Quebec | |
Research Site | Recruiting |
Chicoutimi, Quebec, Canada, G7H 7K9 | |
Research Site | Recruiting |
Levis, Quebec, Canada, G6W 0M5 | |
Research Site | Recruiting |
Montreal, Quebec, Canada, H1T 3Y7 | |
Research Site | Recruiting |
Montreal, Quebec, Canada, H2W 1R7 | |
Research Site | Recruiting |
Montreal, Quebec, Canada, H4A 3T2 | |
Research Site | Recruiting |
St Jerome, Quebec, Canada, J7Z 5T3 | |
Canada | |
Research Site | Recruiting |
Quebec, Canada, G1V 4W2 | |
Czechia | |
Research Site | Recruiting |
Beroun, Czechia, 266 01 | |
Research Site | Recruiting |
Brno, Czechia, 602 00 | |
Research Site | Recruiting |
Brno, Czechia, 603 00 | |
Research Site | Recruiting |
Brno, Czechia, 638 00 | |
Research Site | Recruiting |
Broumov, Czechia, 550 01 | |
Research Site | Recruiting |
Havirov - Mesto, Czechia, 736 01 | |
Research Site | Recruiting |
Hodonin, Czechia, 695 01 | |
Research Site | Recruiting |
Hradec Kralove, Czechia, 500 02 | |
Research Site | Recruiting |
Klatovy IV, Czechia, 339 01 | |
Research Site | Recruiting |
Louny, Czechia, 440 01 | |
Research Site | Recruiting |
Ostrava, Czechia, 702 00 | |
Research Site | Recruiting |
Pardubice, Czechia, 532 03 | |
Research Site | Recruiting |
Praha 10, Czechia, 101 00 | |
Research Site | Recruiting |
Praha 3, Czechia, 130 00 | |
Research Site | Recruiting |
Praha 5 - Smichov, Czechia, 150 00 | |
Research Site | Recruiting |
Rychnov nad Kneznou, Czechia, 516 01 | |
Research Site | Recruiting |
Svitavy, Czechia, 568 25 | |
Research Site | Recruiting |
Trinec, Czechia, 739 61 | |
Research Site | Recruiting |
Uherske Hradiste, Czechia, 686 01 | |
Research Site | Recruiting |
Znojmo, Czechia, 669 02 | |
Denmark | |
Research Site | Recruiting |
Aalborg, Denmark, 9000 | |
Research Site | Recruiting |
Aarhus N, Denmark, 8200 | |
Research Site | Recruiting |
Ballerup, Denmark, 2750 | |
Research Site | Recruiting |
Esbjerg, Denmark, 6700 | |
Research Site | Recruiting |
Gentofte, Denmark, 2820 | |
Research Site | Recruiting |
Herlev, Denmark, 2730 | |
Research Site | Recruiting |
Herning, Denmark, 7400 | |
Research Site | Recruiting |
Hillerod, Denmark, 3400 | |
Research Site | Recruiting |
Kobenhavn O, Denmark, 2100 | |
Research Site | Recruiting |
Kobenhavn S, Denmark, 2300 | |
Research Site | Recruiting |
Kolding, Denmark, 6000 | |
Research Site | Recruiting |
Silkeborg, Denmark, 8600 | |
Research Site | Recruiting |
Svendborg, Denmark, 5700 | |
Research Site | Recruiting |
Vejle, Denmark, 7100 | |
Research Site | Recruiting |
Viborg, Denmark, 8800 | |
France | |
Research Site | Recruiting |
Bron, France, 69677 | |
Research Site | Recruiting |
Grenoble, France, 38700 | |
Research Site | Recruiting |
Le Coudray, France, 28630 | |
Research Site | Recruiting |
Marseille Cedex 08, France, 13285 | |
Research Site | Recruiting |
Nantes Cedex 1, France, 44093 | |
Research Site | Recruiting |
Paris, France, 75012 | |
Research Site | Recruiting |
Paris, France, 75013 | |
Research Site | Recruiting |
Paris, France, 75015 | |
Research Site | Recruiting |
Paris, France, 75018 | |
Research Site | Recruiting |
Rennes, France, 35033 | |
Research Site | Recruiting |
Rouen, France, 76000 | |
Research Site | Recruiting |
Toulouse Cedex 9, France, 31059 | |
Germany | |
Research Site | Recruiting |
Bad Krozingen, Germany, 79189 | |
Research Site | Recruiting |
Bad Neuheim, Germany, 61231 | |
Research Site | Recruiting |
Berlin, Germany, 10787 | |
Research Site | Recruiting |
Berlin, Germany, 13353 | |
Research Site | Recruiting |
Dortmund, Germany, 44137 | |
Research Site | Recruiting |
Dresden, Germany, 01277 | |
Research Site | Recruiting |
Dresden, Germany, 01279 | |
Research Site | Recruiting |
Dresden, Germany, 01307 | |
Research Site | Recruiting |
Fulda, Germany, 36037 | |
Research Site | Recruiting |
Hamburg, Germany, 22041 | |
Research Site | Recruiting |
Heidelberg, Germany, 69120 | |
Research Site | Recruiting |
Kassel, Germany, 34121 | |
Research Site | Recruiting |
Leipzig, Germany, 4103 | |
Research Site | Recruiting |
Magdeburg, Germany, 39120 | |
Research Site | Recruiting |
Mannheim, Germany, 68167 | |
Research Site | Recruiting |
Markleeberg, Germany, 04416 | |
Research Site | Recruiting |
Papenburg, Germany, 26871 | |
Hungary | |
Research Site | Recruiting |
Baja, Hungary, 6500 | |
Research Site | Recruiting |
Balatonfured, Hungary, 8230 | |
Research Site | Recruiting |
Balatonkeresztur, Hungary, 8647 | |
Research Site | Recruiting |
Bekescsaba, Hungary, 5600 | |
Research Site | Recruiting |
Berettyoujfalu, Hungary, 4100 | |
Research Site | Recruiting |
Budapest, Hungary, 1023 | |
Research Site | Recruiting |
Budapest, Hungary, 1085 | |
Research Site | Recruiting |
Budapest, Hungary, 1122 | |
Research Site | Recruiting |
Budapest, Hungary, 1134 | |
Research Site | Recruiting |
Debrecen, Hungary, 4032 | |
Research Site | Recruiting |
Gyongyos, Hungary, 3200 | |
Research Site | Recruiting |
Gyula, Hungary, 5700 | |
Research Site | Recruiting |
Hatvan, Hungary, 3000 | |
Research Site | Recruiting |
Miskolc, Hungary, 3529 | |
Research Site | Recruiting |
Pecs, Hungary, 7624 | |
Research Site | Recruiting |
Sopron, Hungary, 9400 | |
Research Site | Recruiting |
Szeged, Hungary, 6725 | |
Research Site | Recruiting |
Szekesfehervar, Hungary, 8000 | |
Research Site | Recruiting |
Szentes, Hungary, 6600 | |
Research Site | Recruiting |
Szolnok, Hungary, 5004 | |
Research Site | Recruiting |
Zalaegerszeg, Hungary, 8900 | |
Italy | |
Research Site | Recruiting |
Bergamo, Italy, 24127 | |
Research Site | Recruiting |
Catanzaro, Italy, 88100 | |
Research Site | Recruiting |
Chieti, Italy, 66100 | |
Research Site | Recruiting |
Massa, Italy, 54100 | |
Research Site | Recruiting |
Milano, Italy, 20132 | |
Research Site | Recruiting |
Milano, Italy, 20138 | |
Research Site | Recruiting |
Milano, Italy, 20162 | |
Research Site | Recruiting |
Roma, Italy, 00128 | |
Research Site | Recruiting |
San Donato Milanese, Italy, 20097 | |
Research Site | Recruiting |
Torino, Italy, 10126 | |
Research Site | Recruiting |
Udine, Italy, 33100 | |
Korea, Republic of | |
Research Site | Recruiting |
Busan, Korea, Republic of, 49201 | |
Research Site | Recruiting |
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644 | |
Research Site | Recruiting |
Daegu, Korea, Republic of, 42601 | |
Research Site | Recruiting |
Gwangju, Korea, Republic of, 501-757 | |
Research Site | Recruiting |
Seoul, Korea, Republic of, 02841 | |
Research Site | Recruiting |
Seoul, Korea, Republic of, 03080 | |
Research Site | Recruiting |
Seoul, Korea, Republic of, 03181 | |
Research Site | Recruiting |
Seoul, Korea, Republic of, 03722 | |
Research Site | Recruiting |
Seoul, Korea, Republic of, 135-700 | |
Research Site | Recruiting |
Suwon-si, Gyeonggi-do, Korea, Republic of, 16499 | |
Netherlands | |
Research Site | Recruiting |
Alkmaar, Netherlands, 1815 JD | |
Research Site | Recruiting |
Almelo, Netherlands, 7609 PP | |
Research Site | Recruiting |
Almere, Netherlands, 1311 RL | |
Research Site | Recruiting |
Amersfoort, Netherlands, 3813 TZ | |
Research Site | Recruiting |
Amsterdam, Netherlands, 1061 AE | |
Research Site | Recruiting |
Amsterdam, Netherlands, 1091 AC | |
Research Site | Recruiting |
Amsterdam, Netherlands, 1105 AZ | |
Research Site | Recruiting |
Apeldoorn, Netherlands, 7334 DZ | |
Research Site | Recruiting |
Arnhem, Netherlands, 6815 AD | |
Research Site | Recruiting |
Beverwijk, Netherlands, 1942 LE | |
Research Site | Recruiting |
Breda, Netherlands, 4818 CK | |
Research Site | Recruiting |
Delft, Netherlands, 2625 AD | |
Research Site | Recruiting |
Den Haag, Netherlands, 2571 GH | |
Research Site | Recruiting |
Dirksland, Netherlands, 3247 BW | |
Research Site | Recruiting |
Dordrecht, Netherlands, 3318 AT | |
Research Site | Recruiting |
Ede, Netherlands, 6716 RP | |
Research Site | Recruiting |
Eindhoven, Netherlands, 5623 EJ | |
Research Site | Recruiting |
Emmen, Netherlands, 7824 AA | |
Research Site | Recruiting |
Enschede, Netherlands, 7512 KZ | |
Research Site | Recruiting |
Goes, Netherlands, 4462 RA | |
Research Site | Recruiting |
Gouda, Netherlands, 2803 HH | |
Research Site | Recruiting |
Groningen, Netherlands, 9728 NT | |
Research Site | Recruiting |
Heerlen, Netherlands, 6419 PC | |
Research Site | Recruiting |
Helmond, Netherlands, 5707 HA | |
Research Site | Recruiting |
Hoogeveen, Netherlands, 7909 AA | |
Research Site | Recruiting |
Hoorn, Netherlands, 1624 NP | |
Research Site | Recruiting |
Leeuwarden, Netherlands, 8934 AD | |
Research Site | Recruiting |
Leiden, Netherlands, 2333 ZA | |
Research Site | Recruiting |
Meppel, Netherlands, 7943 KA | |
Research Site | Recruiting |
Nieuwegein, Netherlands, 3435 CM | |
Research Site | Recruiting |
Nijmegen, Netherlands, 6525 GA | |
Research Site | Recruiting |
Nijmegen, Netherlands, 6532 SZ | |
Research Site | Recruiting |
Rotterdam, Netherlands, 3045 PM | |
Research Site | Recruiting |
Rotterdam, Netherlands, 3067 GJ | |
Research Site | Recruiting |
Rotterdam, Netherlands, 3079 DZ | |
Research Site | Recruiting |
Rotterdam, Netherlands, 3083 AN | |
Research Site | Recruiting |
Schiedam, Netherlands, 3118 JH | |
Research Site | Recruiting |
Sneek, Netherlands, 8601 ZR | |
Research Site | Recruiting |
The Hague, Netherlands, 2545 AA | |
Research Site | Recruiting |
Tiel, Netherlands, 4002 WP | |
Research Site | Recruiting |
Tilburg, Netherlands, 5042 AD | |
Research Site | Recruiting |
Uden, Netherlands, 5406 PT | |
Research Site | Recruiting |
Utrecht, Netherlands, 3582 KE | |
Research Site | Recruiting |
Utrecht, Netherlands, 3584 CX | |
Research Site | Recruiting |
Venlo, Netherlands, 5912 BL | |
Research Site | Recruiting |
Zaandam, Netherlands, 1502 DV | |
Research Site | Recruiting |
Zwijndrecht, Netherlands, 3331 LZ | |
Research Site | Recruiting |
Zwolle, Netherlands, 8025 AB | |
Poland | |
Research Site | Recruiting |
Gdansk, Poland, 80-462 | |
Research Site | Recruiting |
Gdynia, Poland, 81-394 | |
Research Site | Recruiting |
Gdynia, Poland, 81-472 | |
Research Site | Recruiting |
Grodzisk Mazowiecki, Poland, 05-825 | |
Research Site | Recruiting |
Katowice, Poland, 40-081 | |
Research Site | Recruiting |
Kielce, Poland, 25-525 | |
Research Site | Recruiting |
Kielce, Poland, 25-736 | |
Research Site | Recruiting |
Krakow, Poland, 30-082 | |
Research Site | Recruiting |
Krakow, Poland, 31-501 | |
Research Site | Recruiting |
Krosno, Poland, 38-400 | |
Research Site | Recruiting |
Leczna, Poland, 21-010 | |
Research Site | Recruiting |
Lodz, Poland, 91-347 | |
Research Site | Recruiting |
Lodz, Poland, 93-338 | |
Research Site | Recruiting |
Lodz, Poland, 93-530 | |
Research Site | Recruiting |
Lubin, Poland, 59-300 | |
Research Site | Recruiting |
Lublin, Poland, 20-078 | |
Research Site | Recruiting |
Lublin, Poland, 20-362 | |
Research Site | Recruiting |
Lublin, Poland, 20-857 | |
Research Site | Recruiting |
Miechow, Poland, 32-200 | |
Research Site | Recruiting |
Plock, Poland, 09-402 | |
Research Site | Recruiting |
Poznan, Poland, 60-848 | |
Research Site | Recruiting |
Pulawy, Poland, 24-100 | |
Research Site | Recruiting |
Ruda Slaska, Poland, 41-709 | |
Research Site | Recruiting |
Siedlce, Poland, 08-110 | |
Research Site | Recruiting |
Skierniewice, Poland, 96-100 | |
Research Site | Recruiting |
Staszow, Poland, 28-200 | |
Research Site | Recruiting |
Swidnik, Poland, 21-040 | |
Research Site | Recruiting |
Szczecin, Poland, 70-506 | |
Research Site | Recruiting |
Tarnow, Poland, 33-100 | |
Research Site | Recruiting |
Torun, Poland, 87-100 | |
Research Site | Recruiting |
Warszawa, Poland, 02-507 | |
Research Site | Recruiting |
Warszawa, Poland, 02-793 | |
Research Site | Recruiting |
Warszawa, Poland, 02-957 | |
Research Site | Recruiting |
Wegrow, Poland, 07-100 | |
Research Site | Recruiting |
Wloclawek, Poland, 87-800 | |
Research Site | Recruiting |
Wroclaw, Poland, 50-315 | |
Research Site | Recruiting |
Wroclaw, Poland, 51-162 | |
Research Site | Recruiting |
Zamosc, Poland, 22-400 | |
Russian Federation | |
Research Site | Recruiting |
Arkhangelsk, Russian Federation, 163001 | |
Research Site | Recruiting |
Barnaul, Russian Federation, 656038 | |
Research Site | Recruiting |
Barnaul, Russian Federation, 656055 | |
Research Site | Recruiting |
Ekaterinburg, Russian Federation, 620026 | |
Research Site | Recruiting |
Ekaterinburg, Russian Federation, 620102 | |
Research Site | Recruiting |
Ivanovo, Russian Federation, 153012 | |
Research Site | Recruiting |
Izhevsk, Russian Federation, 426063 | |
Research Site | Recruiting |
Kemerovo, Russian Federation, 650002 | |
Research Site | Recruiting |
Kirov, Russian Federation, 610014 | |
Research Site | Recruiting |
Krasnodar, Russian Federation, 350012 | |
Research Site | Recruiting |
Krasnodar, Russian Federation, 350086 | |
Research Site | Recruiting |
Moscow, Russian Federation, 101990 | |
Research Site | Recruiting |
Moscow, Russian Federation, 111539 | |
Research Site | Recruiting |
Moscow, Russian Federation, 121374 | |
Research Site | Recruiting |
Moscow, Russian Federation, 121552 | |
Research Site | Recruiting |
Nizhny Novgorod, Russian Federation, 603126 | |
Research Site | Recruiting |
Novosibirsk, Russian Federation, 630005 | |
Research Site | Recruiting |
Novosibirsk, Russian Federation, 630047 | |
Research Site | Recruiting |
Novosibirsk, Russian Federation, 630089 | |
Research Site | Recruiting |
Omsk, Russian Federation, 644018 | |
Research Site | Recruiting |
Perm, Russian Federation, 614097 | |
Research Site | Recruiting |
Ryazan, Russian Federation, 390039 | |
Research Site | Recruiting |
Saint Petersburg, Russian Federation, 195112 | |
Research Site | Recruiting |
Saint Petersburg, Russian Federation, 197341 | |
Research Site | Recruiting |
Saint-Petersburg, Russian Federation, 192289 | |
Research Site | Recruiting |
Saint-Petersburg, Russian Federation, 193312 | |
Research Site | Recruiting |
Saint-Petersburg, Russian Federation, 196601 | |
Research Site | Recruiting |
Saint-Petersburg, Russian Federation, 199178 | |
Research Site | Recruiting |
Sait-Petersburg, Russian Federation, 194044 | |
Research Site | Recruiting |
Samara, Russian Federation, 443070 | |
Research Site | Recruiting |
Saratov, Russian Federation, 410054 | |
Research Site | Recruiting |
Smolensk, Russian Federation, 214018 | |
Research Site | Recruiting |
Sochi, Russian Federation, 354057 | |
Research Site | Recruiting |
Tomsk, Russian Federation, 634012 | |
Research Site | Recruiting |
Tyumen, Russian Federation, 625032 | |
Research Site | Recruiting |
Volgograd, Russian Federation, 400001 | |
Spain | |
Research Site | Recruiting |
Almeria, Andalucía, Spain, 04120 | |
Research Site | Recruiting |
Cordoba, Andalucía, Spain, 14004 | |
Research Site | Recruiting |
Granada, Andalucía, Spain, 18012 | |
Research Site | Recruiting |
Malaga, Andalucía, Spain, 29010 | |
Research Site | Recruiting |
Sevilla, Andalucía, Spain, 41009 | |
Research Site | Recruiting |
Zaragoza, Aragón, Spain, 50009 | |
Research Site | Recruiting |
Valladolid, Castilla León, Spain, 47005 | |
Research Site | Recruiting |
Barcelona, Cataluña, Spain, 08025 | |
Research Site | Recruiting |
Barcelona, Cataluña, Spain, 08036 | |
Research Site | Recruiting |
Valencia, Comunidad Valenciana, Spain, 26026 | |
Research Site | Recruiting |
A Coruña, Galicia, Spain, 15706 | |
Research Site | Recruiting |
Santiago de Compostela, Galicia, Spain, 15706 | |
Research Site | Recruiting |
Vigo, Galicia, Spain, 36312 | |
Research Site | Recruiting |
Madrid, Spain, 28702 | |
Sweden | |
Research Site | Recruiting |
Falun, Sweden, 791 82 | |
Research Site | Recruiting |
Goteborg, Sweden, 413 45 | |
Research Site | Recruiting |
Harnosand, Sweden, 871 31 | |
Research Site | Recruiting |
Jonkoping, Sweden, 551 85 | |
Research Site | Recruiting |
Lidkoping, Sweden, 531 85 | |
Research Site | Recruiting |
Malmo, Sweden, 211 52 | |
Research Site | Recruiting |
Ostersund, Sweden, 831 83 | |
Research Site | Recruiting |
Stockholm, Sweden, 114 46 | |
Research Site | Recruiting |
Umea, Sweden, 901 85 | |
Taiwan | |
Research Site | Recruiting |
Hualien, Taiwan, 97002 | |
Research Site | Recruiting |
Kaohsiung, Taiwan, 80756 | |
Research Site | Recruiting |
Kaohsiung, Taiwan, 83301 | |
Research Site | Recruiting |
New Taipei, Taiwan, 25160 | |
Research Site | Recruiting |
Taichung, Taiwan, 40201 | |
Research Site | Recruiting |
Taichung, Taiwan, 40705 | |
Research Site | Recruiting |
Tainan, Taiwan, 70403 | |
Research Site | Recruiting |
Taipei, Taiwan, 10002 | |
Research Site | Recruiting |
Taipei, Taiwan, 11217 | |
Research Site | Recruiting |
Taoyuan, Taiwan, 33305 | |
United Kingdom | |
Research Site | Recruiting |
Aberdeen, United Kingdom, AB25 2ZN | |
Research Site | Recruiting |
Barnsley, United Kingdom, S75 2EP | |
Research Site | Recruiting |
Bath, United Kingdom, BA1 3NG | |
Research Site | Recruiting |
Belfast, United Kingdom, BT16 1RH | |
Research Site | Recruiting |
Belfast, United Kingdom, BT7 2EB | |
Research Site | Recruiting |
Bollington, United Kingdom, SK10 5JH | |
Research Site | Recruiting |
Bournemouth, United Kingdom, BH7 7DW | |
Research Site | Recruiting |
Bristol, United Kingdom, BS37 4AX | |
Research Site | Recruiting |
Burton-on-Trent, United Kingdom, DE13 0RB | |
Research Site | Recruiting |
Chesterfield, United Kingdom, S40 4AA | |
Research Site | Recruiting |
Cleveleys, United Kingdom, FY5 3LF | |
Research Site | Recruiting |
Corby, United Kingdom, NN17 2UR | |
Research Site | Recruiting |
Corby, United Kingdom, NN18 9EZ | |
Research Site | Recruiting |
Crawley, United Kingdom, RH10 7DX | |
Research Site | Recruiting |
Dundee, United Kingdom, DD1 9SY | |
Research Site | Recruiting |
Glasgow, United Kingdom, G31 2ER | |
Research Site | Recruiting |
Hull, United Kingdom, HU3 2RW | |
Research Site | Recruiting |
Kenilworth, United Kingdom, CV8 1JD | |
Research Site | Completed |
Leamington Spa, United Kingdom, CV32 4RA | |
Research Site | Recruiting |
Liverpool, United Kingdom, L7 8XP | |
Research Site | Recruiting |
Manchester, United Kingdom, M23 9LT | |
Research Site | Recruiting |
Newport, United Kingdom, PO30 5TG | |
Research Site | Recruiting |
Northwood, United Kingdom, HA6 2RN | |
Research Site | Recruiting |
Nottingham, United Kingdom, NG5 1PB | |
Research Site | Recruiting |
Nuneaton, United Kingdom, CV10 7DJ | |
Research Site | Recruiting |
Penzance, United Kingdom, TR19 7HX | |
Research Site | Recruiting |
Poole, United Kingdom, BH16 5PW | |
Research Site | Recruiting |
Romford, United Kingdom, RM1 3PJ | |
Research Site | Recruiting |
Sandbach, United Kingdom, CW11 1EQ | |
Research Site | Recruiting |
Scunthorpe, United Kingdom, DN15 7BH | |
Research Site | Recruiting |
Shipley, United Kingdom, BD18 3SA | |
Research Site | Recruiting |
Sidcup, United Kingdom, DA14 6LT | |
Research Site | Recruiting |
Stevenage, United Kingdom, SG1 4AB | |
Research Site | Recruiting |
Thetford, United Kingdom, IP24 2HY | |
Research Site | Recruiting |
Torquay, United Kingdom, TQ2 7AA | |
Research Site | Recruiting |
Wakefield, United Kingdom, WF1 4DG | |
Research Site | Recruiting |
Watford, United Kingdom, WD25 7NL | |
Research Site | Recruiting |
West Bromwich, United Kingdom, B71 4HJ | |
Research Site | Recruiting |
Whitby, United Kingdom, YO21 1SD | |
Research Site | Recruiting |
Wokingham, United Kingdom, RG40 1XS | |
Research Site | Recruiting |
Worcester, United Kingdom, WR5 1DD | |
Research Site | Recruiting |
Yeovil, United Kingdom, BA21 4AT |
Study Director: | MD | Amgen |
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT03872401 |
Other Study ID Numbers: |
20170625 2018-004565-14 ( EudraCT Number ) |
First Posted: | March 13, 2019 Key Record Dates |
Last Update Posted: | December 7, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
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. |
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 link below. |
URL: | http://www.amgen.com/datasharing |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
High Cardiovascular Risk No prior Myocardial Infarction stroke >= 50 years of age (men) >= 55 years of age (women) lipid-lowering therapy |
Myocardial Infarction Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Infarction Vascular Diseases Cardiovascular Diseases Ischemia Pathologic Processes |
Necrosis Arteriosclerosis Arterial Occlusive Diseases Evolocumab Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |