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 range30 Years – 75 Years
SexALL
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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:
✓. 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)
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
. 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%