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.