The Revacept/CS/02 phase II trial was designed to evaluate the safety and efficacy of a single dose of Revacept in 158 patients with symptomatic carotid artery stenosis, with clinical results not reported in this design and rationale paper.
RCT (n=158)
Double-blind
Minimized randomization
Yes
Does a single dose of Revacept reduce new ischemic brain lesions and cardiovascular events in patients with symptomatic carotid artery stenosis?
This paper describes the design and rationale of a phase II trial evaluating the safety and efficacy of Revacept, a novel GPVI fusion protein, for reducing periprocedural embolization in patients with symptomatic carotid artery stenosis.
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.
Gröschel et al. (2020) conducted an RCT in Symptomatic carotid artery stenosis (n=158). Revacept vs. Placebo was evaluated on New diffusion-weighted imaging (DWI) lesions on MRI (exploratory). The Revacept/CS/02 phase II trial was designed to evaluate the safety and efficacy of a single dose of Revacept in 158 patients with symptomatic carotid artery stenosis, with clinical results not reported in this design and rationale paper.