Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
158 participants
INTERVENTIONAL
2013-03-08
2019-09-23
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol
Placebo control with PBS, 1% sucrose and 4% mannitol
Placebo
single intravenous injection
40 mg Revacept
low dose Revacept 40mg in PBS, 1% sucrose, 4% mannitol
Revacept
single intravenous injection
120 mg Revacept
high dose revacept 120mg in PBS, 1% sucrose, 4% mannitol
Revacept
single intravenous injection
Interventions
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Revacept
single intravenous injection
Placebo
single intravenous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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)
18 Years
ALL
No
Sponsors
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AdvanceCor GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Holger Poppert, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, TU Munich
Ian M Loftus, MD
Role: PRINCIPAL_INVESTIGATOR
St George's NHS Trust
Locations
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Site 01: Department of Neurology, TU Munich
Munich, Bavaria, Germany
Site 08: Universitätsklinikum Essen, Klinik für Neurologie
Essen, , Germany
Site 11: Universitätsklinikum Hamburg Eppendorf
Hamburg, , Germany
Site 07: Medizinische Hochschule Hannover, Klinik für Neurologie
Hanover, , Germany
Site 12: Universitätsklinikum Leipzig AöR
Leipzig, , Germany
Site 09: Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie
Mainz, , Germany
Site 04: Universitätsklinikum Tübingen, Klinik für Allgemeine Neurologie
Tübingen, , Germany
Site 06: Universitätsklinikum Ulm, Abteilung für Neurologie
Ulm, , Germany
Site 23 - University Hospital Coventry NHS Trust
Coventry, , United Kingdom
Site 26 - University College London Hospital
London, , United Kingdom
Site 28 - King's College London Hospital
London, , United Kingdom
Site 20: St George's NHS Trust
London, , United Kingdom
Countries
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References
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Bultmann A, Li Z, Wagner S, Peluso M, Schonberger T, Weis C, Konrad I, Stellos K, Massberg S, Nieswandt B, Gawaz M, Ungerer M, Munch G. Impact of glycoprotein VI and platelet adhesion on atherosclerosis--a possible role of fibronectin. J Mol Cell Cardiol. 2010 Sep;49(3):532-42. doi: 10.1016/j.yjmcc.2010.04.009. Epub 2010 Apr 27.
Goertler M, Baeumer M, Kross R, Blaser T, Lutze G, Jost S, Wallesch CW. Rapid decline of cerebral microemboli of arterial origin after intravenous acetylsalicylic acid. Stroke. 1999 Jan;30(1):66-9. doi: 10.1161/01.str.30.1.66.
Markus HS, Droste DW, Kaps M, Larrue V, Lees KR, Siebler M, Ringelstein EB. Dual antiplatelet therapy with clopidogrel and aspirin in symptomatic carotid stenosis evaluated using doppler embolic signal detection: the Clopidogrel and Aspirin for Reduction of Emboli in Symptomatic Carotid Stenosis (CARESS) trial. Circulation. 2005 May 3;111(17):2233-40. doi: 10.1161/01.CIR.0000163561.90680.1C. Epub 2005 Apr 25.
Massberg S, Konrad I, Bultmann A, Schulz C, Munch G, Peluso M, Lorenz M, Schneider S, Besta F, Muller I, Hu B, Langer H, Kremmer E, Rudelius M, Heinzmann U, Ungerer M, Gawaz M. Soluble glycoprotein VI dimer inhibits platelet adhesion and aggregation to the injured vessel wall in vivo. FASEB J. 2004 Feb;18(2):397-9. doi: 10.1096/fj.03-0464fje. Epub 2003 Dec 4.
Molloy J, Markus HS. Asymptomatic embolization predicts stroke and TIA risk in patients with carotid artery stenosis. Stroke. 1999 Jul;30(7):1440-3. doi: 10.1161/01.str.30.7.1440.
Nieswandt B, Watson SP. Platelet-collagen interaction: is GPVI the central receptor? Blood. 2003 Jul 15;102(2):449-61. doi: 10.1182/blood-2002-12-3882. Epub 2003 Mar 20.
Ringelstein EB, Droste DW, Babikian VL, Evans DH, Grosset DG, Kaps M, Markus HS, Russell D, Siebler M. Consensus on microembolus detection by TCD. International Consensus Group on Microembolus Detection. Stroke. 1998 Mar;29(3):725-9. doi: 10.1161/01.str.29.3.725.
Schonberger T, Siegel-Axel D, Bussl R, Richter S, Judenhofer MS, Haubner R, Reischl G, Klingel K, Munch G, Seizer P, Pichler BJ, Gawaz M. The immunoadhesin glycoprotein VI-Fc regulates arterial remodelling after mechanical injury in ApoE-/- mice. Cardiovasc Res. 2008 Oct 1;80(1):131-7. doi: 10.1093/cvr/cvn169. Epub 2008 Jun 19.
Ungerer M, Rosport K, Bultmann A, Piechatzek R, Uhland K, Schlieper P, Gawaz M, Munch G. Novel antiplatelet drug revacept (Dimeric Glycoprotein VI-Fc) specifically and efficiently inhibited collagen-induced platelet aggregation without affecting general hemostasis in humans. Circulation. 2011 May 3;123(17):1891-9. doi: 10.1161/CIRCULATIONAHA.110.980623. Epub 2011 Apr 18.
Jamasbi J, Megens RT, Bianchini M, Munch G, Ungerer M, Faussner A, Sherman S, Walker A, Goyal P, Jung S, Brandl R, Weber C, Lorenz R, Farndale R, Elia N, Siess W. Differential Inhibition of Human Atherosclerotic Plaque-Induced Platelet Activation by Dimeric GPVI-Fc and Anti-GPVI Antibodies: Functional and Imaging Studies. J Am Coll Cardiol. 2015 Jun 9;65(22):2404-15. doi: 10.1016/j.jacc.2015.03.573.
Kleiman NS, Kolandaivelu K. Expanding the Roster: Developing New Inhibitors of Intravascular Thrombosis. J Am Coll Cardiol. 2015 Jun 9;65(22):2416-9. doi: 10.1016/j.jacc.2015.03.576. No abstract available.
Uphaus T, Richards T, Weimar C, Neugebauer H, Poli S, Weissenborn K, Imray C, Michalski D, Rashid H, Loftus I, Rummey C, Ritter M, Hauser TK, Munch G, Groschel K, Poppert H. Revacept, an Inhibitor of Platelet Adhesion in Symptomatic Carotid Stenosis: A Multicenter Randomized Phase II Trial. Stroke. 2022 Sep;53(9):2718-2729. doi: 10.1161/STROKEAHA.121.037006. Epub 2022 Jun 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Revacept/CS/02
Identifier Type: -
Identifier Source: org_study_id
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