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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01645306
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
AdvanceCor GmbH

Tracking Information
First Submitted Date  ICMJE July 16, 2012
First Posted Date  ICMJE July 20, 2012
Last Update Posted Date December 19, 2019
Actual Study Start Date  ICMJE March 8, 2013
Actual Primary Completion Date October 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2015)
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 Measures  ICMJE
 (submitted: July 19, 2012)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2015)
  • 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 Measures  ICMJE
 (submitted: July 19, 2012)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Revacept in Symptomatic Carotid Stenosis (Revacept/CS/02)
Official Title  ICMJE 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 Groups
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Carotid Stenosis
  • Atherosclerosis
  • Stroke
  • Transient-ischaemic Attack
  • TIA
  • Amaurosis Fugax
Intervention  ICMJE
  • Drug: Revacept
    single intravenous injection
  • Drug: Placebo
    single intravenous injection
Study Arms  ICMJE
  • Placebo Comparator: Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol
    Intervention: Drug: Placebo
  • Active Comparator: 40 mg Revacept
    in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol
    Intervention: Drug: Revacept
  • Active Comparator: 120 mg Revacept
    in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol
    Intervention: Drug: Revacept
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2018)
158
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2012)
150
Actual Study Completion Date  ICMJE September 23, 2019
Actual Primary Completion Date October 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed written informed consent
  2. Target population

    • Diagnosis:

      • Extracranial carotid artery stenosis (diagnosed by vascular duplex ultrasound peak flow or angiography)
      • Lesions with ≥ 50 % stenosis according to the European Carotid Surgery Trial (ECST) criteria
      • TIA, amaurosis fugax or stroke within the last 30 days
    • Age and sex: Men and women aged > 18 years Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after receiving investigational product in such a manner that the risk of pregnancy is minimised.

Exclusion Criteria:

  1. Sex and reproductive Status:

    • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product.
    • Women who are pregnant or breastfeeding
    • Women with a positive pregnancy test on enrollment or prior to investigational product administration.
  2. Target disease exceptions

    • NIHSS score > 18
    • Recent intracerebral haemorrhage by X-ray computed tomography (CT) or nuclear magnetic resonance (NMR)
    • Cardiac cause of embolisation (atrial fibrillation or other cardiac source e.g. artificial heart valves)
  3. Medical history and concurrent disease

    • History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation, hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug
    • History or evidence of thrombocytopenia (<30.000/ul), bleeding diathesis or coagulopathy (pathological international normalised ratio (INR) or activated partial thromboplastin time (aPTT))
    • Thrombolysis within the last 48 hours
    • Relevant haemorrhagic transformation as determined by CT, NMR or anamnesis
    • Oral anticoagulation or dual anti-platelet therapy with aspirin or clopidogrel and other P2Y inhibitors at screening (3 days for dipyridamole extended release; 8 hours for tirofiban/Aggrastat)
    • Sustained hypertension (systolic BP > 179 mmHg or diastolic BP >109 mmHg)
    • History of severe systemic disease such as terminal carcinoma, renal failure (or current creatinine > 200 umol/l), cirrhosis, severe dementia, or psychosis
    • Current severe liver dysfunction (transaminase level greater than 5-fold over upper normal range limit)
    • Active autoimmune disorder such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis or glomerulonephritis
    • Known atrial fibrillation or other clinically significant ECG abnormalities (at present)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01645306
Other Study ID Numbers  ICMJE Revacept/CS/02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AdvanceCor GmbH
Study Sponsor  ICMJE AdvanceCor GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Holger Poppert, PD Dr. med. Department of Neurology, TU Munich
Principal Investigator: Ian M Loftus, MD St George's NHS Trust
PRS Account AdvanceCor GmbH
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP