Effect of Evolocumab on Vascular Function

Sponsor
University of Erlangen-Nürnberg Medical School
Study ID
NCT03626831
Phase
PHASE4
Status
Completed

Conditions

  • Atherosclerotic Cardiovascular Disease

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a phase IV, randomized (1:1), prospective, double-blind, placebo controlled, parallel-group, single center study at the Clinical Research Unit (CRC) of the Department of Nephrology and Hypertension, with its two separate locations: * Nürnberg, Kreuzburger Str. 2, 90471 Nürnberg, and * Erlangen, Ulmenweg 18, 91054 Erlangen The results of this study provide strong support for the concept that it is lower LDL-C levels that is key to achieving better outcomes, and that it is possible to achieve these on top of statin therapy (despite the much debated potential "pleiotropic" effects of statins). At least 65 patients will be randomized (1:1) and included (informed consent) in order to obtain 58 fully evaluable subjects (29 with evolocumab, 29 with placebo). Patients will be simultaneously recruited from investigator's outpatient clinics, referring physicians, and advertisement in local newspapers, and social media. Those patients that appear to potentially fulfill the inclusion criteria will be invited to a screening visit. After providing informed consent, patients will be tested for inclusion/exclusion criteria and for feasibility of vascular measurements (in particular to ensure that adequate imaging of the brachial artery is possible). Patients will provide a blood sample for laboratory testing. If the patient then fulfills inclusion criteria and in the absence of exclusion criteria, the patient will be enrolled into the trial, and the study visits will be scheduled. Randomization will take place at the latest one day prior to the study visit 2 (e.g. at the latest at visit 2a). At visit 2, baseline vascular function parameters will be obtained and the patient will be given an SC injection of the study drug (either SC 420 mg evolocumab or SC placebo). At visit 4, the second injection of study drug will be administered. After 1, 4 and 8 weeks of treatment (visits 3, 4 and 5), testing of vascular function will be repeated. At visit 6, a final close out visits will be performed to gather additional safety information.

Key Dates

Start date
Apr 4, 2019
Status verified
Jul 2023
Primary completion
Apr 15, 2021
Completion
Jul 12, 2021

Study Design

Enrollment
105 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment
    Baseline vascular function parameters will be obtained and the patient will be given an SC injection of the study drug by Evolocumab Prefilled Syringe (1x SC 420 mg evolocumab).
  • Placebo Comparator: Placebo
    Baseline vascular function parameters will be obtained and the patient will be given an SC injection of Placebos (1x SC Placebo).

Primary Outcome Measure

Percent change of FMD [ Time Frame: 8 weeks ]

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