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

This study is currently recruiting participants.
Verified June 2017 by AdvanceCor GmbH
Sponsor:
ClinicalTrials.gov Identifier:
NCT01645306
First Posted: July 20, 2012
Last Update Posted: July 2, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AdvanceCor GmbH
  Purpose

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 Intervention Phase
Carotid Stenosis Atherosclerosis Stroke Transient-ischaemic Attack TIA Amaurosis Fugax Drug: Revacept Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AdvanceCor GmbH:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: March 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


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

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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01645306


Contacts
Contact: Holger Poppert, PD Dr. med. 004989-4140 ext 4606

Locations
Germany
Site 01: Department of Neurology, TU Munich Recruiting
Munich, Bavaria, Germany, 81675
Contact: Holger Poppert, PD Dr. med.    +49 89 4140 ext 4606      
Principal Investigator: Holger Poppert, PD Dr. med.         
Site 08: Universitätsklinikum Essen, Klinik für Neurologie Recruiting
Essen, Germany, 45147
Contact: Melanie Dietzold         
Principal Investigator: Christian Weimar, Prof. Dr. med.         
Site 11: Universitätsklinikum Hamburg Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Dagmar Otto         
Contact: Kirsten Jaramillo         
Principal Investigator: Götz Thomalla, PD Dr. med.         
Principal Investigator: Amir Golsari, Dr. med.         
Site 07: Medizinische Hochschule Hannover, Klinik für Neurologie Recruiting
Hannover, Germany, 30625
Contact: Hans Worthmann, Dr. med.    +49 511 532 ext 3580      
Principal Investigator: Karin Weißenborn, Prof. Dr. med.         
Principal Investigator: Hans Worthmann, Dr. med.         
Site 12: Universitätsklinikum Leipzig AöR Not yet recruiting
Leipzig, Germany, 04103
Contact: Daniela Urban         
Contact: Rita Lachmund         
Principal Investigator: Dominik Michalski, PD Dr. med.         
Site 09: Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie Recruiting
Mainz, Germany, 55131
Contact: Klaus Gröschel, PD Dr. med.         
Principal Investigator: Klaus Gröschel, PD Dr. med.         
Sub-Investigator: Timo Uphaus         
Site 04: Universitätsklinikum Tübingen, Klinik für Allgemeine Neurologie Recruiting
Tübingen, Germany, 72076
Contact: Sven Poli, Dr. med.    07071 29 ext 84427      
Contact: Julia Zeller         
Principal Investigator: Sven Poli, Dr. med.         
Principal Investigator: Ziemann Ulf, Prof. Dr. med.         
Site 06: Universitätsklinikum Ulm, Abteilung für Neurologie Recruiting
Ulm, Germany, 89081
Contact: Sabine Raubold    +49 731 177 ext 5721      
Principal Investigator: Hermann Neugebauer, Dr. med.         
Principal Investigator: Katharina Knauer, Dr. med.         
United Kingdom
Site 23 - University Hospital Coventry NHS Trust Recruiting
Coventry, United Kingdom, CV2 2DX
Contact: Chris Imray, MD         
Principal Investigator: Chris Imray, MD         
Site 26 - University College London Hospital Recruiting
London, United Kingdom, NW1 2BU
Contact: Toby Richards, MD         
Principal Investigator: Toby Richards, MD         
Site 28 - King's College London Hospital Recruiting
London, United Kingdom, SE5 8AF
Contact: Hisham Rashid         
Principal Investigator: Hisham Rashid         
Site 20: St George's NHS Trust Recruiting
London, United Kingdom, SW17 0QT
Principal Investigator: Ian M Loftus, MD         
Sponsors and Collaborators
AdvanceCor GmbH
Investigators
Principal Investigator: Holger Poppert, PD Dr. med. Department of Neurology, TU Munich
Principal Investigator: Ian M Loftus, MD St George's NHS Trust
  More Information

Publications:

Responsible Party: AdvanceCor GmbH
ClinicalTrials.gov Identifier: NCT01645306     History of Changes
Other Study ID Numbers: Revacept/CS/02
First Submitted: July 16, 2012
First Posted: July 20, 2012
Last Update Posted: July 2, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Vision Disorders
Constriction, Pathologic
Atherosclerosis
Ischemic Attack, Transient
Carotid Stenosis
Blindness
Amaurosis Fugax
Pathological Conditions, Anatomical
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Carotid Artery Diseases
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs