Effect of Evolocumab on Vascular Function (EVO)
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|ClinicalTrials.gov Identifier: NCT03626831|
Recruitment Status : Not yet recruiting
First Posted : August 13, 2018
Last Update Posted : October 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerotic Cardiovascular Disease||Drug: Evolocumab Prefilled Syringe Drug: Placebos||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized (1:1), prospective, double-blind, placebo controlled, parallel-group|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||double blind|
|Official Title:||Randomized, Double-blind, Placebo Controlled, Parallel-group, Prospective Clinical Study to Analyse the Effect of Evolocumab on Vascular Function|
|Estimated Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||August 2020|
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).
Drug: Evolocumab Prefilled Syringe
Injection of study drug
Placebo Comparator: Placebo
Baseline vascular function parameters will be obtained and the patient will be given an SC injection of Placebos (1x SC Placebo).
Injection of placebo
- Percent change of FMD [ Time Frame: 8 weeks ]Percent change of FMD (UNEX EF) after 8 weeks of treatment from baseline
- Absolute change of FMD (UNEX EF) [ Time Frame: 8 weeks ]Absolute change of FMD (UNEX EF) after 8 weeks of treatment from baseline
- Absolute change of L-FMC [ Time Frame: 8 weeks ]Absolute change of L-FMC after treatment from baseline and across all visits
- Percent change of L-FMC [ Time Frame: 8 weeks ]Percent change of L-FMC after treatment from baseline and across all visits
- Absolute change of combined FMD+L-FMC (UNEX EF) [ Time Frame: 8 weeks ]Absolute change of combined FMD+L-FMC (UNEX EF) after treatment from baseline and across all visits.
- Percent change of combined FMD+L-FMC (UNEX EF) [ Time Frame: 8 weeks ]Percent change of combined FMD+L-FMC (UNEX EF) after treatment from baseline and across all visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626831
|Contact: Roland E Schmieder, MD||+49 9131 85 ext email@example.com|
|Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg|
|Erlangen, Germany, 91054|
|Principal Investigator:||Roland E Schmieder, MD||University Hospital Erlangen|