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Clinical Trial Details

Trial ID: L5014
Source ID: NCT03932721
Associated Drug: Evolocumab 140 Mg/Ml
Title: EXpanded Combination of Evolocumab Plus Empagliflozin on Diabetes: EXCEED-BHS3 Trial
Acronym: EXCEED-BHS3
Status: COMPLETED
Study Results: NO
Results:
Conditions: Dyslipidemia Associated With Type II Diabetes Mellitus|Diabetes Mellitus, Type 2|Hypertension Arterial
Interventions: DRUG: Evolocumab 140 MG/ML
Outcome Measures: Primary: Difference in the percentage change in flow mediated dilation (FMD), Difference in the change in flow mediated dilation (FMD) between the randomization visit and at 16 weeks of treatment. Brachial artery measurements will be performed using a high-resolution ultrasound obtained by physicians with long experience in this exam. The FMD scan will be measured on Video clips recorded from 1 minute before cuff inflation to 5 minutes after deflation. Percentage change in diameter for FMD will be calculated in relation to the respective baseline scans., 16 weeks | Secondary: Difference in the percentage change in FMD reserve, Difference in the change in FMD reserve (change after ischemia/reperfusion) between the randomization visit and at 16 weeks of treatment. FMD reserve will be estimated by the difference between rest and post-ischemia assessment. Briefly, FMD will be assessed at rest and repeated after 30 minutes of brachial ischemia followed by 15 minutes of reperfusion. The percentage difference between baseline and post-ischemia FMD will be considered as FDM reserve., 16 weeks | Other: Difference in the change of plasma NO in mmol/L, Difference in the change of plasma NO in mmol/L after FMD at the randomization visit and at 16 weeks of treatment., 16 weeks|Difference in the change of plasma VCAM-1 in pg/mL, Difference in the change of plasma VCAM-1 in pg/mL at the randomization visit and at 16 weeks of treatment., 16 weeks|Difference in the percentage change in FMD from randomization to 8 weeks of treatment., Difference in the percentage change in FMD between the randomization visit and at 8 weeks of treatment., 8 weeks|Difference in the percentage change in FMD reserve from randomization to 8 weeks of treatment., Difference in the change in FMD reserve between the randomization visit and at 8 weeks of treatment., 8 weeks|Difference in the change in plasma isoprostane in pg/mL from randomization to 16 weeks of treatment., Difference in the change in plasma isoprostane in pg/mL between the randomization visit and at 16 weeks of treatment., 16 weeks|Difference in the percentage change of LDL subfractions from randomization to 16 weeks of treatment., Difference in the percentage change of the distribution of LDL subespecies between the randomization visit and at 16 weeks of treatment., 16 weeks|Difference in the Change of Ambulatorial Blood Pressure (mm Hg) from randomization to 16 weeks of treatment., Difference in the Change of Ambulatorial Blood Pressure (mm Hg) between the randomization visit and at 16 weeks of treatment., 16 weeks|Difference in Plasma C-Reactive Protein Change in mg/dL from randomization to 16 weeks of treatment., Difference in Plasma C-Reactive Protein Change in mg/dL between treatments from randomization visit to 16 weeks of treatment., 16 weeks
Sponsor/Collaborators: Sponsor: University of Campinas, Brazil
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 110
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2018-10-01
Completion Date: 2021-10-30
Results First Posted:
Last Update Posted: 2023-03-09
Locations: Centro de Pesquisa Clinica - FCM/Unicamp, Campinas, SP, 13083-887, Brazil
URL: https://clinicaltrials.gov/show/NCT03932721