Clinical Trial: Revacept in Symptomatic Carotid Stenosis (Revacept/CS/02)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Revacept, an Inhibitor of Platelet Adhesion in Symptomatic Carotid Stenosis: A Phase II, Multicentre; Randomised, Dose-finding, Double-blind and Placebo Controlled Superiority Study With Parallel Grou

Brief Summary:

Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks (TIAs), amaurosis fugax or stroke receive either Revacept (single dose) plus antiplatelet monotherapy or monotherapy alone.

Patients receive a single dose of trial medication by intravenous infusion for 20 minutes. Patients are followed up one and three days after treatment, at 3 months and by a telephone interview at 12 months.


Detailed Summary:
Sponsor: AdvanceCor GmbH

Current Primary Outcome: Assessment of incidence of microembolic signals (MES) [ Time Frame: 24 hours after treatment ]

In patients with symptomatic carotid artery stenosis who have been treated with Revacept plus antiplatelet monotherapy versus antiplatelet monotherapy alone (placebo). MES will be assessed by transcranial Doppler (TCD) examination.


Original Primary Outcome: Change in incidence of microembolic signals (MES) [ Time Frame: 24 hours after treatment ]

The primary efficacy objective is to evaluate whether the incidence of preoperative microembolic signals (MES) can be reduced in patients with symptomatic carotid artery stenosis who have been treated with Revacept plus antiplatelet monotherapy (aspirin or clopidogrel) versus antiplatelet monotherapy alone (placebo) prior to carotid endarterectomy (CEA). MES will be assessed by transcranial Doppler (TCD) examination.


Current Secondary Outcome:

  • Change in rate of MES per hour [ Time Frame: 24 hours after treatment ]
  • Assessment of neurological status (NIH Stroke Scale) [ Time Frame: 3 months after treatment ]
  • Cerebral lesion analysis by DWI-NMR [ Time Frame: 1 day after CEA / intervention ]
  • Clinical endpoint rate of all cause death [ Time Frame: up to 12 months after treatment ]
  • Assessment of cardiovascular outcome [ Time Frame: 3 and 12 months ]
    myocardial infarction and re-intervention
  • Change in vital signs [ Time Frame: up to 3 months after treatment ]
  • Change in ECG parameters [ Time Frame: up to 3 months after treatment ]
  • Assessment of anti-drug antibody titres [ Time Frame: up to 3 months after treatment ]
  • Assessment of Adverse Events [ Time Frame: up to 3 months after treatment ]
    including wound healing complications, laboratory abnormalities and use of concomitant medication
  • Where feasible: Assessment of Haemostasis Safety [ Time Frame: up to 3 months after treatment ]
    laboratory parameters indicating thrombocytopenia and bleeding according to the RE-LY study group criteria, in vitro platelet function, in vitro bleeding time by PFA-100 / PFA-200
  • Clinical endpoint rate of stroke-related death [ Time Frame: up to 12 months after treatment ]
  • Clinical endpoint TIA, amaurosis fugax or stroke including haemorrhagic stroke [ Time Frame: up to 12 months after treatment ]


Original Secondary Outcome:

  • Change in rate of MES per hour [ Time Frame: 24 hours after treatment ]
  • Assessment of neurological status (NIH Stroke Scale) [ Time Frame: 3 months after treatment ]
  • Cerebral lesion analysis by DWI-NMR and correlation to neurological status [ Time Frame: 1 day after CEA ]
  • Clinical endpoints [ Time Frame: up to 12 months after treatment ]
    • Rate of all cause death
    • Rate of stroke-related death
    • Any TIA or stroke including haemorrhagic stroke
  • Assessment of cardiovascular outcome [ Time Frame: 3 and 12 months ]
    myocardial infarction and re-intervention
  • Change in vital signs [ Time Frame: up to 3 months after treatment ]
  • Change in ECG parameters [ Time Frame: up to 3 months after treatment ]
  • Assessment of anti-drug antibody titres [ Time Frame: up to 3 months after treatment ]
  • Assessment of Adverse Events [ Time Frame: up to 3 months after treatment ]
    including wound healing complications, laboratory abnormalities and use of concomitant medication
  • Assessment of Haemostasis Safety [ Time Frame: up to 3 months after treatment ]
    laboratory parameters indicating thrombocytopenia and bleeding according to the RE-LY study group criteria, in vitro platelet function, in vitro bleeding time by PFA-100


Information By: AdvanceCor GmbH

Dates:
Date Received: July 16, 2012
Date Started: March 2013
Date Completion: December 2017
Last Updated: July 14, 2016
Last Verified: July 2016