Revacept in Symptomatic Carotid Stenosis

• Status: Completed
• Trial end date: 2019-09-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AdvanceCor GmbH
• Treatments: Mannitol

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)