Extra Alirocumab in Addition to Statin Therapy in Symptomatic IntraCranial Atherosclerotic Stenos… (NCT06052020) | Clinical Trial Compass
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Extra Alirocumab in Addition to Statin Therapy in Symptomatic IntraCranial Atherosclerotic Stenosis ----a Pilot Study
China50 participantsStarted 2023-09-15
Plain-language summary
The primary goal of the trial is to investigate whether the lipid lowering strategy using Alirocumab plus statin could cause more changes from baseline in intracranial atherosclerotic plaque and hemodynamic features during 6 months of follow-up, in patients with recent stroke/transient ischemic attack (TIA) caused by intracranial artery stenosis.
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 6 weeks prior to randomization.
✓. Modified Rankin score of ≤ 4.
✓. 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 high resolution MR.
✓. 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 target vessels/plaques. In case that patients who receive surgeries during follow-up, they will still be followed up for 1 year.
✕. Intracranial tumor (except meningioma) or any intracranial vascular malformation.
What they're measuring
1
Plaque burden (PB)
Timeframe: This will be assessed at 6 months after recruitment.
2
Degree of stenosis caused by the plaque
Timeframe: This will be assessed at 6 months after recruitment.
3
Plaque enhancement
Timeframe: This will be assessed at 6 months after recruitment.
4
Remodeling index (RI) of the plaque
Timeframe: This will be assessed at 6 months after recruitment.
5
Presence of T1 hyperintensity in the plaque
Timeframe: This will be assessed at 6 months after recruitment.
6
Plaque distribution: whether it is a concentric plaque or not
Timeframe: This will be assessed at 6 months after recruitment.
7
Hemodynamic characteristics: Hypoperfusion volume
Timeframe: This will be assessed at 6 months after recruitment.
Trial details
NCT IDNCT06052020
SponsorThe First Affiliated Hospital with Nanjing Medical University
✕. 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%.
✕. Use of cholesteryl ester transfer protein (CETP) inhibition treatment, mipomersen, or lomitapide within 12 months prior to randomization. Fenofibrate therapy must be stable for at least 6 weeks prior to final screening at a dose that is appropriate for the duration of the study in the judgment of the investigator. Other fibrate therapy (and derivatives) are prohibited.
✕. Prior use of PCSK9 inhibition treatment before this recruitment.