Revacept in Symptomatic Carotid Stenosis
Condition: Carotid Stenosis; Atherosclerosis; Stroke; Transient-ischaemic Attack; TIA; Amaurosis Fugax
MeSH terms: Ischemic Attack, Transient; Carotid Stenosis; Blindness; Amaurosis Fugax; Atherosclerosis; Constriction, Pathologic
Intervention: Revacept; Placebo
Intervention description: single intravenous injection; single intravenous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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)