Hypercholesterolemia Clinical Trial
— GLAGOVOfficial title:
A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization
| Verified date | February 2019 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.
| Status | Completed |
| Enrollment | 970 |
| Est. completion date | July 29, 2016 |
| Est. primary completion date | July 12, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
Inclusion Criteria: - Clinical indication for coronary angiography - Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria - Fasting LDL-C = 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C = 60 -< 80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors Subjects must meet the following criteria at the qualifying coronary catheterization procedure: - Evidence of coronary heart disease (at least one lesion in a native coronary artery that has > 20% reduction in lumen diameter) or prior percutaneous intervention (PCI) - Left main coronary artery < 50% reduction in lumen diameter by visual estimation - Target coronary artery for IVUS must be accessible to the IVUS catheter, must not have a > 50% reduction in lumen diameter within the target segment (and at least 40 mm in length); cannot have undergone prior PCI or coronary artery bypass graft (CABG) and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous myocardial infarction (MI). Exclusion Criteria: - Coronary artery bypass graft surgery < 6 weeks prior to the qualifying IVUS - New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction less than 30% - Uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization - Known hemorrhagic stroke - Uncontrolled hypertension at randomization - Fasting Triglycerides = 400 mg/dL (4.5 mmol/L) at screening - Type 1 diabetes or poorly controlled type 2 diabetes (hemoglobin A1c [HbA1c] > 9%) at screening. - Moderate to severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m²) at screening. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Ciudad Autonoma de Buenos Aires | Buenos Aires |
| Argentina | Research Site | Ciudad Autonoma de Buenos Aires | Buenos Aires |
| Argentina | Research Site | Cordoba | Córdoba |
| Argentina | Research Site | Cordoba | Córdoba |
| Argentina | Research Site | Córdoba | |
| Argentina | Research Site | Corrientes | |
| Argentina | Research Site | La Plata | Buenos Aires |
| Argentina | Research Site | Rosario | Santa Fe |
| Australia | Research Site | Adelaide | South Australia |
| Australia | Research Site | Bedford Park | South Australia |
| Australia | Research Site | Chermside | Queensland |
| Australia | Research Site | Concord | New South Wales |
| Australia | Research Site | Darlinghurst | New South Wales |
| Australia | Research Site | Epping | Victoria |
| Australia | Research Site | Footscray | Victoria |
| Australia | Research Site | Heidelberg | Victoria |
| Australia | Research Site | Herston | Queensland |
| Australia | Research Site | Liverpool | New South Wales |
| Australia | Research Site | Melbourne | Victoria |
| Australia | Research Site | Nedlands | Western Australia |
| Australia | Research Site | New Lambton Heights | New South Wales |
| Belgium | Research Site | Antwerpen | |
| Belgium | Research Site | Brussels | |
| Belgium | Research Site | Bruxelles | |
| Belgium | Research Site | Edegem | |
| Belgium | Research Site | Genk | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Hasselt | |
| Belgium | Research Site | Lodelinsart | |
| Brazil | Research Site | Cariacica | Espírito Santo |
| Brazil | Research Site | Curitiba | Paraná |
| Brazil | Research Site | Goiania | Goiás |
| Brazil | Research Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | Research Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | Research Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | Research Site | Sao Paulo | São Paulo |
| Brazil | Research Site | São Paulo | |
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Halifax | Nova Scotia |
| Canada | Research Site | Laval | Quebec |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Quebec City | Quebec |
| Canada | Research Site | Saint John | New Brunswick |
| Canada | Research Site | St. Johns | Newfoundland and Labrador |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Victoria | British Columbia |
| Canada | Research Site | Winnipeg | Manitoba |
| Chile | Research Site | Santiago | |
| Chile | Research Site | Santiago | |
| Chile | Research Site | Santiago | |
| Chile | Research Site | Temuco | Cautín |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Hradec Kralove | |
| Czechia | Research Site | Praha 2 | |
| Czechia | Research Site | Praha 4 | |
| Czechia | Research Site | Usti nad Labem | |
| Czechia | Research Site | Zlin | |
| Denmark | Research Site | Aarhus N | |
| Denmark | Research Site | Odense C | |
| France | Research Site | Besançon Cedex | |
| France | Research Site | Chambray les Tours | |
| France | Research Site | Creteil | |
| France | Research Site | Marseille cedex 5 | |
| France | Research Site | Paris | |
| France | Research Site | Pessac Cedex | |
| Germany | Research Site | Aachen | |
| Germany | Research Site | Essen | |
| Germany | Research Site | München | |
| Germany | Research Site | Neuss | |
| Germany | Research Site | Regensburg | |
| Germany | Research Site | Ulm | |
| Greece | Research Site | Alexandroupoli | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Heraklion | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Debrecen | |
| Hungary | Research Site | Pecs | |
| Hungary | Research Site | Szeged | |
| Iceland | Research Site | Reykjavik | |
| Ireland | Research Site | Dublin | |
| Ireland | Research Site | Galway | |
| Israel | Research Site | Hadera | |
| Israel | Research Site | Jerusalem | |
| Israel | Research Site | Rehovot | |
| Italy | Research Site | Novara | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Rozzano MI | |
| Italy | Research Site | Sesto San Giovanni (MI) | |
| Italy | Research Site | Torino | |
| Korea, Republic of | Research Site | Daejeon | |
| Korea, Republic of | Research Site | Seongnam-si | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Malaysia | Research Site | Kuantan | Pahang |
| Malaysia | Research Site | Penang | |
| Mexico | Research Site | Aguascalientes | |
| Mexico | Research Site | Culiacan | Sinaloa |
| Mexico | Research Site | Guadalajara | Jalisco |
| Mexico | Research Site | Puebla | |
| Mexico | Research Site | Queretaro | Querétaro |
| Mexico | Research Site | San Luis Potosi | San Luis Potosí |
| Netherlands | Research Site | Alkmaar | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Eindhoven | |
| Netherlands | Research Site | Leeuwarden | |
| Netherlands | Research Site | Nieuwegein | |
| Netherlands | Research Site | Nijmegen | |
| Netherlands | Research Site | Rotterdam | |
| Netherlands | Research Site | Tilburg | |
| Netherlands | Research Site | Utrecht | |
| Netherlands | Research Site | Venlo | |
| Netherlands | Research Site | Zwolle | |
| Norway | Research Site | Oslo | |
| Norway | Research Site | Tromso | |
| Philippines | Research Site | Pasig City | |
| Philippines | Research Site | Quezon City | |
| Philippines | Research Site | Quezon City | |
| Poland | Research Site | Chrzanow | |
| Poland | Research Site | Kedzierzyn Kozle | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Warszawa | |
| Russian Federation | Research Site | Kemerovo | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Singapore | Research Site | Singapore | |
| South Africa | Research Site | Boksburg | Gauteng |
| South Africa | Research Site | Centurion | Gauteng |
| South Africa | Research Site | Johannesburg | Gauteng |
| South Africa | Research Site | Kuils River | Western Cape |
| South Africa | Research Site | Pinelands, Cape Town | Western Cape |
| South Africa | Research Site | Somerset West | Western Cape |
| Spain | Research Site | Barcelona | Cataluña |
| Spain | Research Site | Gijon | Asturias |
| Spain | Research Site | L Hospitalet De Llobregat | Cataluña |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Malaga | Andalucía |
| Spain | Research Site | Santiago de Compostela | Galicia |
| Sweden | Research Site | Göteborg | |
| Sweden | Research Site | Helsingborg | |
| Sweden | Research Site | Lund | |
| Sweden | Research Site | Örebro | |
| Sweden | Research Site | Solna | |
| Sweden | Research Site | Stockholm | |
| Switzerland | Research Site | Geneva 14 | |
| Switzerland | Research Site | St. Gallen | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | New Taipei | |
| Taiwan | Research Site | Taichung City | |
| Taiwan | Research Site | Taipei | |
| United Kingdom | Research Site | Newcastle Upon Tyne | |
| United States | Research Site | Amarillo | Texas |
| United States | Research Site | Ann Arbor | Michigan |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Atlantis | Florida |
| United States | Research Site | Bay City | Michigan |
| United States | Research Site | Bethesda | Maryland |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Canton | Ohio |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Columbia | Missouri |
| United States | Research Site | Columbia | Maryland |
| United States | Research Site | Covington | Louisiana |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Doylestown | Pennsylvania |
| United States | Research Site | Duluth | Minnesota |
| United States | Research Site | Elyria | Ohio |
| United States | Research Site | Fargo | North Dakota |
| United States | Research Site | Grand Rapids | Michigan |
| United States | Research Site | Hammond | Indiana |
| United States | Research Site | Hershey | Pennsylvania |
| United States | Research Site | Hillsboro | Oregon |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Johnson City | New York |
| United States | Research Site | La Jolla | California |
| United States | Research Site | La Jolla | California |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Marquette | Michigan |
| United States | Research Site | Melbourne | Florida |
| United States | Research Site | Midland | Michigan |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Missoula | Montana |
| United States | Research Site | Mobile | Alabama |
| United States | Research Site | Newport Beach | California |
| United States | Research Site | Oak Ridge | Tennessee |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Orange | California |
| United States | Research Site | Petoskey | Michigan |
| United States | Research Site | Ridgewood | New Jersey |
| United States | Research Site | Safety Harbor | Florida |
| United States | Research Site | Saginaw | Michigan |
| United States | Research Site | Saint Cloud | Minnesota |
| United States | Research Site | Saint Paul | Minnesota |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | Santa Monica | California |
| United States | Research Site | Springfield | Oregon |
| United States | Research Site | Toledo | Ohio |
| United States | Research Site | Torrance | California |
| United States | Research Site | Tulsa | Oklahoma |
| United States | Research Site | Valparaiso | Indiana |
| United States | Research Site | Washington | District of Columbia |
| United States | Research Site | Wichita Falls | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, Denmark, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJ, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Scott R, Ungi I, Podolec J, Ophuis AO, Cornel JH, Borgman M, Brennan DM, Nissen SE. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA. 2016 Dec 13;316(22):2373-2384. doi: 10.1001/jama.2016.16951. — View Citation
Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJP, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Honda S, Shishikura D, Scherer DJ, Borgman M, Brennan DM, Wolski K, Nissen SE. Effect of Evolocumab on Coronary Plaque Composition. J Am Coll Cardiol. 2018 Oct 23;72(17):2012-2021. doi: 10.1016/j.jacc.2018.06.078. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Percent Atheroma Volume at Week 78 | Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a = 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma. | Baseline and week 78 | |
| Secondary | Change From Baseline in Total Atheroma Volume at Week 78 | Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a = 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants. | Baseline and week 78 | |
| Secondary | Percentage of Participants With Regression in Percent Atheroma Volume | Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a = 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma. Regression in PAV was defined as any reduction from baseline in PAV. |
Baseline and week 78 | |
| Secondary | Percentage of Participants With Regression in Total Atheroma Volume | Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a = 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants. Regression in TAV was defined as any reduction from baseline in TAV. |
Baseline and week 78 |
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