Revacept in Symptomatic Carotid Stenosis (RevaceptCS02)
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ClinicalTrials.gov Identifier: NCT01645306 |
Recruitment Status :
Completed
First Posted : July 20, 2012
Results First Posted : January 28, 2021
Last Update Posted : January 28, 2021
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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 |
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.
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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol
Placebo control with PBS, 1% sucrose and 4% mannitol
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Drug: Placebo
single intravenous injection
Other Name: Control Group |
Active Comparator: 40 mg Revacept
low dose Revacept 40mg in PBS, 1% sucrose, 4% mannitol
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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
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Drug: Revacept
single intravenous injection
Other Name: 40 mg or 120 mg |
- 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).
- 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.
- Major Bleedings [ Time Frame: 90 days after IMP application ]patients with major bleedings occuring within 90 days after IMP application
- 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.
- 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.
- 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 |
Inclusion Criteria:
- Signed written informed consent
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Target population
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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.
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Exclusion Criteria:
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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.
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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)
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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)

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
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 |
Principal Investigator: | Holger Poppert, Prof. Dr. | Department of Neurology, TU Munich | |
Principal Investigator: | Ian M Loftus, MD | St George's NHS Trust |
Documents provided by AdvanceCor GmbH:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
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 |