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Revacept in Symptomatic Carotid Stenosis (RevaceptCS02)

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
Results First Posted : January 28, 2021
Last Update Posted : January 28, 2021
Sponsor:
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

Detailed Description:

Patients had a more than 50% carotid artery stenosis according to ECST and suffered from ischemic stroke, transitory ischemic attack or intermittent blindness (amaurosis fugax) within the last 30 days. All patients were on standard medication with aspirin or clopidogrel and received heparin for thrombosis prophylaxis. Carotid endarterectomy (CEA), carotid stenting (CAS) or best medical therapy for treatment of the carotid stenosis and prevention of secondary thrombo-emboli was performed according to guidelines. Additional treatment with Revacept or placebo was done on top of the standard therapy. Therefore the control group receiving placebo was already on the standard medical therapy for patients with symptomatic carotid stenosis and received also the guideline conform interventions CEA, CAS or best medical therapy.

Secondary prophylaxis of thrombo-embolic ischemic events by Revacept should be investigated. Therefore microemboli were detected by transcranial Doppler and ischemic brain lesions were investigated by diffusion weighted imaging magnetic resonance imaging (DWI-MRI) scan as exploratory endpoints. Moreover clinical endpoints such as stroke, TIA, myocardial infarction, coronary intervention and death were investigated at 1 week, 3 months and 12 months follow-up. Safety was closely monitored with emphasis on bleeding complications as bleeding is the most dreaded complication of anti-thrombotic agents especially in patients with cerebral strokes.

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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
Placebo control with PBS, 1% sucrose and 4% mannitol
Drug: Placebo
single intravenous injection
Other Name: Control Group

Active Comparator: 40 mg Revacept
low dose Revacept 40mg in PBS, 1% sucrose, 4% mannitol
Drug: Revacept
single intravenous injection
Other Name: 40 mg or 120 mg

Active Comparator: 120 mg Revacept
high dose revacept 120mg in PBS, 1% sucrose, 4% mannitol
Drug: Revacept
single intravenous injection
Other Name: 40 mg or 120 mg




Primary Outcome Measures :
  1. New DWI Lesion(s) [ Time Frame: 1 day post intervention ]
    The number of new diffusion weighted imaging (DWI) lesion(s) reported. (1 day after intervention compared to baseline).


Other Outcome Measures:
  1. Patients With Any Stroke or Transient Ischemic Attack (TIA) [ Time Frame: 90 days after IMP application ]
    patients with any stroke or TIA occuring within 90 days after IMP application.

  2. Major Bleedings [ Time Frame: 90 days after IMP application ]
    patients with major bleedings occuring within 90 days after IMP application

  3. Any Clinical Event [ Time Frame: 365 days after IMP application ]
    patients with any stroke & TIA, myocardial infarction & percutaneous coronary intervention (PCI), death or bleeding within one year (365 days) after IMP application.

  4. Anti-Drug Antibodies [ Time Frame: 3 month (+/- 1 month) after IMP application ]

    Anti-drug antibodies were measured at baseline and 3 month after IMP application.

    Number of patients with positive anti-drug antibodies compared to baseline are counted.


  5. Participants With Adverse Events (AEs) [ Time Frame: ~ 365 days after IMP application (whole study period) ]
    All adverse events were assessed during complete study period (~ 1 year after IMP application).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

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


Locations
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Germany
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
Investigators
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Principal Investigator: Holger Poppert, Prof. Dr. Department of Neurology, TU Munich
Principal Investigator: Ian M Loftus, MD St George's NHS Trust
  Study Documents (Full-Text)

Documents provided by AdvanceCor GmbH:
Study Protocol  [PDF] June 22, 2015
Statistical Analysis Plan  [PDF] June 10, 2019

Publications:

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Responsible Party: AdvanceCor GmbH
ClinicalTrials.gov Identifier: NCT01645306    
Other Study ID Numbers: Revacept/CS/02
First Posted: July 20, 2012    Key Record Dates
Results First Posted: January 28, 2021
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Carotid Stenosis
Blindness
Amaurosis Fugax
Atherosclerosis
Constriction, Pathologic
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
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases