Phase 2
N=158
Revacept in Symptomatic Carotid Stenosis
Carotid Stenosis · Atherosclerosis · Stroke · Transient-ischaemic Attack · TIA
Bottom Line
View on ClinicalTrials.gov: NCT01645306 ↗Enrolled (actual)
158
Serious AEs
31.0%
Results posted
Jan 2021
Primary outcome: Primary: New DWI Lesion(s) — 1.2; 1.0; 0.6 Number of new lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Revacept (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AdvanceCor GmbH
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY New DWI Lesion(s) |
1.2; 1.0; 0.6 | — |
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
- 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.