Anticoagulation Using Rivaroxaban on Top of Aspirin in Intracranial Atherosclerotic Stenosis (NCT05700266) | Clinical Trial Compass
UnknownPhase 2/3
Anticoagulation Using Rivaroxaban on Top of Aspirin in Intracranial Atherosclerotic Stenosis
1,180 participantsStarted 2023-12-30
Plain-language summary
The primary goal of the clinical trial is to test the effect of oral rivaroxaban plus aspirin in patients with recent stroke/ transient ischemic attack (TIA) caused by intracranial artery stenosis. Participants will be divided into 2 groups to receive either oral rivaroxaban plus aspirin or oral clopidogrel plus aspirin. The main question it aims to answer is whether the experimental group (oral rivaroxaban plus aspirin) is superior to the control group ( oral clopidogrel plus aspirin) to lower recurrent stroke/TIA or death in these patients during 1 year of follow-up.
Who can participate
Age range
30 Years – 75 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 ≥ 30 years and ≤ 75 years
. TIA or Acute ischemic stroke that occurred within 30 days prior to randomization.
. Modified Rankin score of ≤ 3
. TIA or Acute ischemic stroke attributed to a 50 to 99% stenosis of a major intracranial artery (internal carotid artery \[ICA\], vertebral artery \[VA\], basilar artery \[BA\] and the M1 segment of middle cerebral artery \[MCA\]). The diagnostic evaluation for ICAS at each site is confirmed by the local investigator, using magnetic resonance angiography (MRA), or computerized tomographic angiography (CTA), high resolution MR, or digital substraction angiography (DSA).
. To increase the likelihood that the symptomatic intracranial stenosis is atherosclerotic, patients aged 30-49 years are required to meet at least one additional criteria (i-vi) below:
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
any stroke (ischemic or hemorrhagic) or death during 1 year of follow-up
Timeframe: the primary outcome will be assessed during 1 year of follow-up after recruitments.
Trial details
NCT IDNCT05700266
SponsorThe First Affiliated Hospital with Nanjing Medical University
. Patient agrees with follow-up visits and is available by phone.
. Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.
Exclusion criteria
. Previous treatment of target intracranial lesion with a stent, angioplasty, or other mechanical devices (e.g. mechanical thrombectomy, coil embolization)
. Plan to perform angioplasty, stenting, coiling, thrombectomy, endarterectomy or aneurysmal coil embolization for any other cerebral blood vessels (common carotid artery \[CCA\], ICA, VA, MCA, anterior cerebral artery \[ACA\], posterior cerebral artery \[PCA\] et al)
. Intracranial tumor (except meningioma) or any intracranial vascular malformation
. Thrombolytic therapy within 24 hours prior to randomization
. Progressive neurological signs within 24 hours prior to enrollment
. History of any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural)
. Intracranial arterial stenosis due to arterial dissection; MoyaMoya disease; any known vasculitic disease; viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebral spinal fluid pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process; reversible cerebral vasoconstriction syndrome (RCVS); suspected recanalized embolus
. Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%