Phase 2
Completed N=158
Revacept in Symptomatic Carotid Stenosis
Source: ClinicalTrials.gov NCT01645306 ↗Enrolled (actual)
158
Serious AEs
31.0%
Results posted
Jan 2021
Primary outcomePrimary: New DWI Lesion(s) — 1.2; 1.0; 0.6 Number of new lesions
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY New DWI Lesion(s) |
1.2; 1.0; 0.6 | — |
Eligibility Criteria
Inclusion Criteria
- Signed written informed consent
- 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
- 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.
- 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)
- 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 ( 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)
Data sourced from ClinicalTrials.gov (NCT01645306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.