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Clinical Trial Details

Trial ID: L6081
Source ID: NCT03829046
Associated Drug: Placebo
Title: The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03829046/results
Conditions: Atherosclerotic Vascular Disease|Type2 Diabetes|Microvascular Dysfunction
Interventions: DRUG: Placebo|DRUG: Evolocumab
Outcome Measures: Primary: Number of Adverse Events, Safety as measured by number of adverse events, defined as any untoward medical occurrence in a subject who has been administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment., up to 12 weeks | Secondary: Seattle Angina Questionnaire, The Seattle Angina Questionnaire is a quality-of-life measure for patients with coronary artery disease. The SAQ is a self-report instrument with 19 items that yields five subscale scores: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. There is no summary score generated., 12 weeks|MDA Level, Malondialdehyde levels to measure oxidative stress, 12 weeks|MPO Level, Myeloperoxidase level to measure inflammation, 12 weeks|IL-6 Level, Interleukin-6 levels to measure cytokines, 12 weeks|IL-18 Level, Interleukin-8 levels to measure cytokines, 12 weeks|TNF-α Level, Tumor necrosis factor alpha levels to measure cytokines, 12 weeks|PECAM Level, Platelet endothelial cell adhesion molecule levels to measure vascular endothelial activation, 12 weeks|ICAM Level, Intercellular adhesion molecule levels to measure vascular endothelial activation, 12 weeks|VCAM Level, Vascular cell adhesion molecule levels to measure vascular endothelial activation, 12 weeks|Alpha5/Beta3 Activation Levels, Alpha 5/Beta 3 levels to measure vascular endothelial activation, 12 weeks
Sponsor/Collaborators: Sponsor: Robert Rosenson | Collaborators: Amgen|University of Toronto|University of Michigan
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 41
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2019-06-03
Completion Date: 2021-11-15
Results First Posted: 2023-03-08
Last Update Posted: 2023-03-08
Locations: Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States|St. Michael's - University of Toronto, Toronto, Ontario, M5B1W8, Canada
URL: https://clinicaltrials.gov/show/NCT03829046