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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. Identifier: NCT01645306
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : December 19, 2019
Information provided by (Responsible Party):
AdvanceCor GmbH

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.

Condition or disease Intervention/treatment Phase
Carotid Stenosis Atherosclerosis Stroke Transient-ischaemic Attack TIA Amaurosis Fugax Drug: Revacept Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Groups
Actual Study Start Date : March 8, 2013
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : September 23, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol Drug: Placebo
single intravenous injection

Active Comparator: 40 mg Revacept
in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol
Drug: Revacept
single intravenous injection

Active Comparator: 120 mg Revacept
in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol
Drug: Revacept
single intravenous injection

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Change in rate of MES per hour [ Time Frame: 24 hours after treatment ]
  2. Assessment of neurological status (NIH Stroke Scale) [ Time Frame: 3 months after treatment ]
  3. Cerebral lesion analysis by DWI-NMR [ Time Frame: 1 day after CEA / intervention ]
  4. Clinical endpoint rate of all cause death [ Time Frame: up to 12 months after treatment ]
  5. Assessment of cardiovascular outcome [ Time Frame: 3 and 12 months ]
    myocardial infarction and re-intervention

  6. Change in vital signs [ Time Frame: up to 3 months after treatment ]
  7. Change in ECG parameters [ Time Frame: up to 3 months after treatment ]
  8. Assessment of anti-drug antibody titres [ Time Frame: up to 3 months after treatment ]
  9. Assessment of Adverse Events [ Time Frame: up to 3 months after treatment ]
    including wound healing complications, laboratory abnormalities and use of concomitant medication

  10. 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

  11. Clinical endpoint rate of stroke-related death [ Time Frame: up to 12 months after treatment ]
  12. Clinical endpoint TIA, amaurosis fugax or stroke including haemorrhagic stroke [ Time Frame: up to 12 months after treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01645306

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Site 01: Department of Neurology, TU Munich
Munich, Bavaria, Germany, 81675
Site 08: Universitätsklinikum Essen, Klinik für Neurologie
Essen, Germany, 45147
Site 11: Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Site 07: Medizinische Hochschule Hannover, Klinik für Neurologie
Hannover, Germany, 30625
Site 12: Universitätsklinikum Leipzig AöR
Leipzig, Germany, 04103
Site 09: Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie
Mainz, Germany, 55131
Site 04: Universitätsklinikum Tübingen, Klinik für Allgemeine Neurologie
Tübingen, Germany, 72076
Site 06: Universitätsklinikum Ulm, Abteilung für Neurologie
Ulm, Germany, 89081
United Kingdom
Site 23 - University Hospital Coventry NHS Trust
Coventry, United Kingdom, CV2 2DX
Site 26 - University College London Hospital
London, United Kingdom, NW1 2BU
Site 28 - King's College London Hospital
London, United Kingdom, SE5 8AF
Site 20: St George's NHS Trust
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
AdvanceCor GmbH
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Principal Investigator: Holger Poppert, PD Dr. med. Department of Neurology, TU Munich
Principal Investigator: Ian M Loftus, MD St George's NHS Trust

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Responsible Party: AdvanceCor GmbH Identifier: NCT01645306    
Other Study ID Numbers: Revacept/CS/02
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Carotid Stenosis
Amaurosis Fugax
Constriction, Pathologic
Pathological Conditions, Anatomical
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Carotid Artery Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases