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CC BY 4.0 · TH Open 2020; 04(04): e393-e399
DOI: 10.1055/s-0040-1721078
Original Article

Revacept, an Inhibitor of Platelet Adhesion in Symptomatic Carotid Artery Stenosis: Design and Rationale of a Randomized Phase II Clinical Trial

Klaus Gröschel 
1   Department of Neurology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
,
Timo Uphaus
1   Department of Neurology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
,
Ian Loftus
2   Department of Vascular Surgery, St George's University Hospitals NHS Foundation Trust, London, United Kingdom
,
Holger Poppert
3   Department of Neurology, Klinikum rechts der Isar, Technical University Munich, Munich, Germany
,
Hans Christoph Diener
4   Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty of the University Duisburg-Essen, Essen, Germany
,
Jenny Zobel
5   advanceCOR, Munich, Germany
,
Götz Münch
5   advanceCOR, Munich, Germany
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Abstract

Patients with stroke or transient ischemic attacks (TIAs) and internal carotid artery stenosis harbor an increased risk of recurrent stroke especially within 2 weeks after the first event. In addition, the revascularization procedure itself (carotid endarterectomy [CEA] or carotid artery stenting [CAS]) is associated with both clinically apparent and silent brain infarctions, mainly caused by the embolic nature of the ruptured carotid plaque. The glycoprotein VI (GPVI) fusion protein Revacept is a highly specific antithrombotic drug without direct inhibition of systemic platelet function that might reduce periprocedural distal embolization from the vulnerable ruptured plaque located at the internal carotid artery. By shielding collagen at the site of vascular injury, Revacept inhibits plaque-mediated platelet adhesion and aggregation, while not directly affecting systemic hemostasis. In this phase II study, 158 patients with symptomatic carotid artery stenosis with recent TIA or stroke were randomized to receive a single dose of either Revacept (40 or 120 mg) or placebo. All patients were on standard secondary preventive therapy (statins and platelet inhibition) and underwent CEA, CAS, or best medical therapy according to current guidelines. The efficacy of Revacept was evaluated by exploratory assessment of new diffusion-weighted imaging lesions on magnetic resonance imaging after the revascularization procedure; a combination of cardiovascular events (ischemic and hemorrhagic stroke, TIA, myocardial infarction, or coronary intervention) and bleeding complications served to assess clinically critical patients' outcome and safety. This exploratory phase II randomized, double-blind clinical trial provides valuable insights on the safety, tolerability, and efficacy of Revacept in patients with symptomatic carotid artery stenosis.

Keywords

Revacept - platelet inhibitor - transient ischemic attack - carotid stenosis - stroke

Note

ClinicalTrials.gov Identifier: NCT01645306.




Publication History

Received: 22 July 2020

Accepted: 09 October 2020

Article published online:
30 November 2020

© 2020. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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