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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by AdvanceCor GmbH
Sponsor:
Information provided by (Responsible Party):
AdvanceCor GmbH
ClinicalTrials.gov Identifier:
NCT01645306
First received: July 16, 2012
Last updated: September 30, 2014
Last verified: September 2014

July 16, 2012
September 30, 2014
March 2013
September 2014   (final data collection date for primary outcome measure)
Change in incidence of microembolic signals (MES) [ Time Frame: 24 hours after treatment ] [ Designated as safety issue: No ]
The primary efficacy objective is to evaluate whether the incidence of microembolic signals (MES) can be reduced in patients with symptomatic carotid artery stenosis who have been treated with Revacept plus antiplatelet monotherapy (aspirin or clopidogrel) versus antiplatelet monotherapy alone (placebo). MES will be assessed by transcranial Doppler (TCD) examination.
Change in incidence of microembolic signals (MES) [ Time Frame: 24 hours after treatment ] [ Designated as safety issue: No ]
The primary efficacy objective is to evaluate whether the incidence of preoperative microembolic signals (MES) can be reduced in patients with symptomatic carotid artery stenosis who have been treated with Revacept plus antiplatelet monotherapy (aspirin or clopidogrel) versus antiplatelet monotherapy alone (placebo) prior to carotid endarterectomy (CEA). MES will be assessed by transcranial Doppler (TCD) examination.
Complete list of historical versions of study NCT01645306 on ClinicalTrials.gov Archive Site
  • Change in rate of MES per hour [ Time Frame: 24 hours after treatment ] [ Designated as safety issue: No ]
  • Assessment of neurological status (NIH Stroke Scale) [ Time Frame: 3 months after treatment ] [ Designated as safety issue: Yes ]
  • Cerebral lesion analysis by DWI-NMR and correlation to neurological status [ Time Frame: 1 day after CEA / intervention ] [ Designated as safety issue: Yes ]
  • Clinical endpoint rate of all cause death [ Time Frame: up to 12 months after treatment ] [ Designated as safety issue: Yes ]
  • Assessment of cardiovascular outcome [ Time Frame: 3 and 12 months ] [ Designated as safety issue: Yes ]
    myocardial infarction and re-intervention
  • Change in vital signs [ Time Frame: up to 3 months after treatment ] [ Designated as safety issue: Yes ]
  • Change in ECG parameters [ Time Frame: up to 3 months after treatment ] [ Designated as safety issue: Yes ]
  • Assessment of anti-drug antibody titres [ Time Frame: up to 3 months after treatment ] [ Designated as safety issue: Yes ]
  • Assessment of Adverse Events [ Time Frame: up to 3 months after treatment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Clinical endpoint TIA, amaurosis fugax or stroke including haemorrhagic stroke [ Time Frame: up to 12 months after treatment ] [ Designated as safety issue: Yes ]
  • Change in rate of MES per hour [ Time Frame: 24 hours after treatment ] [ Designated as safety issue: No ]
  • Assessment of neurological status (NIH Stroke Scale) [ Time Frame: 3 months after treatment ] [ Designated as safety issue: Yes ]
  • Cerebral lesion analysis by DWI-NMR and correlation to neurological status [ Time Frame: 1 day after CEA ] [ Designated as safety issue: Yes ]
  • Clinical endpoints [ Time Frame: up to 12 months after treatment ] [ Designated as safety issue: Yes ]
    • Rate of all cause death
    • Rate of stroke-related death
    • Any TIA or stroke including haemorrhagic stroke
  • Assessment of cardiovascular outcome [ Time Frame: 3 and 12 months ] [ Designated as safety issue: Yes ]
    myocardial infarction and re-intervention
  • Change in vital signs [ Time Frame: up to 3 months after treatment ] [ Designated as safety issue: Yes ]
  • Change in ECG parameters [ Time Frame: up to 3 months after treatment ] [ Designated as safety issue: Yes ]
  • Assessment of anti-drug antibody titres [ Time Frame: up to 3 months after treatment ] [ Designated as safety issue: Yes ]
  • Assessment of Adverse Events [ Time Frame: up to 3 months after treatment ] [ Designated as safety issue: Yes ]
    including wound healing complications, laboratory abnormalities and use of concomitant medication
  • Assessment of Haemostasis Safety [ Time Frame: up to 3 months after treatment ] [ Designated as safety issue: Yes ]
    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
Not Provided
Not Provided
 
Revacept in Symptomatic Carotid Stenosis (Revacept/CS/02)
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

Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks (TIAs), amaurosis fugax or stroke and presenting with microembolic signals (MES) receive either Revacept (single dose) plus antiplatelet monotherapy (Aspirin or Clopidogrel) or monotherapy alone with the aim of reducing MES.

Patients receive a single dose of trial medication by intravenous infusion for 20 minutes. The primary endpoint (MES 24 hours after treatment) is assessed. Patients are followed up one and three days after treatment, at 3 months and by a telephone interview at 12 months.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Carotid Stenosis
  • Atherosclerosis
  • Stroke
  • Transient-ischaemic Attack
  • TIA
  • Amaurosis Fugax
  • Drug: Revacept
    single intravenous injection
  • Drug: Placebo
    single intravenous injection
  • Placebo Comparator: Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol
    Intervention: Drug: Placebo
  • Active Comparator: 40 mg Revacept
    in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol
    Intervention: Drug: Revacept
  • Active Comparator: 120 mg Revacept
    in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol
    Intervention: Drug: Revacept

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2014
September 2014   (final data collection date for primary outcome measure)

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
      • MES detected by TCD (greater than or equal to 1 MES per hour)
      • Ipsilateral 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 other anti-platelet therapy than aspirin or clopidogrel within the last 3 weeks (3 days for dipyridamole extended release; 8 hours for tirofiban/Aggrastat)
    • Sustained hypertension (systolic BP > 179 mmHg or diastolic BP >109 mmHg), hypertensive patients shall be treated in accordance with current guidelines for the management of arterial hypertension
    • 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)
  4. Prohibited Treatments and/or therapies

    • Oral anticoagulation or dual antiplatelet therapy (aspirin combined with clopidogrel or other P2Y inhibitors) at screening; dipyridamole extended release within last 3 days; tirofiban/Aggrastat within the last 8 hours
    • Indication for oral anticoagulation
Both
18 Years and older
No
Contact: Holger Poppert, PD Dr. med. 004989-4140 ext 4606
Germany,   United Kingdom
 
NCT01645306
Revacept/CS/02
Yes
AdvanceCor GmbH
AdvanceCor GmbH
Not Provided
Principal Investigator: Holger Poppert, PD Dr. med. Department of Neurology, TU Munich
Principal Investigator: Ian M Loftus, MD St George's NHS Trust
AdvanceCor GmbH
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP