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