Revacept in Symptomatic Carotid Stenosis (Revacept/CS/02) "Revacept/CS/02"

Recruiting

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: single intravenous injection
    ARM 1: Kind: Experimental
    Label: Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol
  • Revacept Drug
    Intervention Desc: single intravenous injection
    ARM 1: Kind: Experimental
    Label: 40 mg Revacept
    Description: in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol
    ARM 2: Kind: Experimental
    Label: 120 mg Revacept
    Description: in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in incidence of microembolic signals (MES) 24 hours after treatment No
Secondary Change in rate of MES per hour 24 hours after treatment No
Secondary Assessment of neurological status (NIH Stroke Scale) 3 months after treatment Yes
Secondary Cerebral lesion analysis by DWI-NMR and correlation to neurological status 1 day after CEA Yes
Secondary Clinical endpoints up to 12 months after treatment Yes
Secondary Assessment of cardiovascular outcome 3 and 12 months Yes
Secondary Change in vital signs up to 3 months after treatment Yes
Secondary Change in ECG parameters up to 3 months after treatment Yes
Secondary Assessment of anti-drug antibody titres up to 3 months after treatment Yes
Secondary Assessment of Adverse Events up to 3 months after treatment Yes
Secondary Assessment of Haemostasis Safety up to 3 months after treatment Yes
Secondary Where feasible: Assessment of Haemostasis Safety up to 3 months after treatment Yes
Secondary Clinical endpoint rate of all cause death up to 12 months after treatment Yes
Secondary Clinical endpoint rate of stroke-related death up to 12 months after treatment Yes
Secondary Clinical endpoint TIA or stroke including haemorrhagic stroke up to 12 months after treatment Yes
Secondary Clinical endpoint TIA, amaurosis fugax or stroke including haemorrhagic stroke up to 12 months after treatment Yes
Primary Assessment of incidence of microembolic signals (MES) 24 hours after treatment No
Secondary Cerebral lesion analysis by DWI-NMR 1 day after CEA / intervention Yes

Sponsors