NCT03626831: EVO

Effect of Evolocumab on Vascular Function

Completed Phase 4 Last updated 11 July 2023

What this trial tests

Phase 4 trial testing Evolocumab Prefilled Syringe in Atherosclerotic Cardiovascular Disease in 105 participants. Completed in 12 July 2021.

Timeline

4 April 2019

Primary endpoint
15 April 2021

12 July 2021

Quick facts

Lead sponsor	University of Erlangen-Nürnberg Medical School
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	105
Start date	4 April 2019
Primary completion	15 April 2021
Estimated completion	12 July 2021
Sites	1 location across Germany

Drugs / interventions tested

• Evolocumab Prefilled Syringe — full drug profile →
• Placebos — full drug profile →

Conditions studied

• Atherosclerotic Cardiovascular Disease — all drugs for Atherosclerotic Cardiovascular Disease →

Sponsor

University of Erlangen-Nürnberg Medical School

Who can join

Adults 40 to 80, any sex, with Atherosclerotic Cardiovascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. PCSK-9-inhibitor therapy improves endothelial function in high-risk patients with cardiovascular disease.
   Kannenkeril D, Bosch A, Kolwelter J, Striepe K, et al · · 2026 · cited 1× · PMID 39565386 · DOI 10.1007/s00392-024-02556-6
2. Endothelial function in high-risk patients with ezetimibe therapy.
   Günes-Altan M, Bosch A, Striepe K, Schiffer M, et al · · 2025 · PMID 40813220 · DOI 10.1016/j.jacl.2025.07.001
3. Endothelial function in high-risk patients with ezetimibe therapy
   Günes-Altan M, Bosch A, Striepe K, Schiffer M, et al · · 2024 · DOI 10.21203/rs.3.rs-4881243/v1
4. 46. Deutscher Hypertonie Kongress "Hypertonie in allen Lebenslagen".
   · 2022 · PMID 36424496 · DOI 10.1007/s15006-022-2031-4