Abciximab for Prevention of Stroke Recurrence Before Endarterectomy in Symptomatic Carotid Stenosis (NCT00126139) | Clinical Trial Compass
TerminatedPhase 3
Abciximab for Prevention of Stroke Recurrence Before Endarterectomy in Symptomatic Carotid Stenosis
Stopped: Higher hemorrhage rates of Abciximab in ABESST II trial
Switzerland100 participantsStarted 2004-04
Plain-language summary
The purpose of the present prospective, randomized, double-blind, double dummy controlled multicenter pilot study is to investigate whether abciximab, compared with aspirin, is able to reduce the rate of recurrent ischemic strokes before and during carotid endarterectomy \[CEA\] (primary endpoints); and the degree of carotid stenosis, number of microembolic signal (MES) counts, number of ischemic infarcts at diffusion weighted imaging (DWI) and amount of intraluminal thrombus at pathological examination (secondary endpoints) in patients with ischemic stroke due to a \>50% carotid stenosis who will undergo CEA.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age at least 18 years.
* Presence of symptoms of an ischemic stroke with a baseline National Institutes of Health Stroke Scale (NIHSS) scale of one up to 20 or due to an ipsilateral atherosclerotic \>50% stenosis of the extracranial internal carotid artery (ICA) as shown by ultrasonography.
* Latency between the onset of stroke symptoms and intended administration of the study drugs is not more than 24 hours.
* Latency between the intended administration of the study drugs and intended carotid endarterectomy is at least three days.
Exclusion Criteria:
* Documented peptic ulcer disease within the preceding 30 days.
* Septicemia or severe localized infection.
* Severe illness (active cancer or significant liver or renal disease) or disability.
* Alcohol or illicit drug abuse.
* Pregnancy.
* Need for chronic anticoagulant therapy (e.g. atrial fibrillation, deep venous thrombosis).
* Need for long-term daily nonsteroidal antiinflammatory drugs.
* Contraindications for platelet therapy such as severe bleeding disorder within the past three months prior to randomization (coagulopathy, platelet disorder including history of heparin-induced thrombopenia, hemorrhage) or significant retinopathy with hemorrhages and exudates.
* Hypersensitivity to abciximab, murine monoclonal antibodies or aspirin.
* Any preexisting intracranial neurological disease such as tumor or multiple sclerosis.
* Intracranial or intraspinal operation or trauma or lumbar puncture within t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Whether abciximab compared with aspirin reduces the rate of recurrent ischemic strokes in territory of symptomatic carotid artery during administration of study drug, preoperative period or carotid endarterectomy