An interventional study of Fingolimod and placebo in Stroke, sponsored by The Affiliated Hospital of Xuzhou Medical University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by The Affiliated Hospital of Xuzhou Medical University · Not applicable, Interventional, and Treatment
Acute ischemic stroke (AIS) is a common type of stroke in the elderly. Timely blood flow recovery can effectively improve the long-term prognosis of patients. According to five large-scale multicenter randomized controlled trials (MR clean, swift-prime, revascat, escape and extend-ia) in recent years, the effect of endovascular therapy (EVT) for acute anterior circulation occlusion of great vessels is significantly better than that of drug therapy alone. Therefore, for patients who meet the "Chinese guidelines for the diagnosis and treatment of acute ischemic stroke" (2018 Edition), the effect of EVT is better than that of drug therapy alone, Intravenous thrombolysis within 4.5 hours and endovascular mechanical thrombectomy within 6 hours can effectively relieve the clinical symptoms and reduce the mortality of AIS. However, due to the narrow application time window of intravenous thrombolysis and mechanical thrombectomy, although the thrombectomy time window of some eligible patients was relaxed to 24 hours after dawn and defuse3 and other related studies, the reperfusion injury after the blocked cerebral artery recanalization has brought huge obstacles to clinical application. Therefore, how to improve the prognosis of patients with endovascular therapy has become a hot research direction.
Fingomod is a kind of sphingosine analogues acting on sphingosine-1-phosphate (sipr). After phosphorylation in the body, fingomod combines with lymphocyte SIP receptor, changes lymphocyte migration route, prevents it from entering the area outside the lymphoid tissue, so as to avoid its infiltration into the central nervous system and achieve immunosuppression. Currently, it is the first-line disease modifying oral drug for multiple sclerosis. Fingolmod shows neuroprotective effects on many central nervous system diseases including cerebral ischemia. Fingomod not only reduced the number of lymphocytes invading the brain, but also decreased the number of lymphocytes in the microcirculation system
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →The Affiliated Hospital of Xuzhou Medical University is the lead sponsor of 66 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be treated with intravascular therapy and fingomod.
Drug: Fingolimod
Patients will be treated with intravascular therapy and placebo.
Drug: placebo
fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days
placebo once daily, for three consecutive days,
90 day mRS score
recovery
Time frame: at day 90
mRS score of 0-1 (%)
excellent recovery
Time frame: at day 90
mRS score of 1-2 (%)
general recovery
Time frame: at day 90
Recanalization success rate
baseline mTICI score - 2 day mTICIS score
Time frame: from baseline to 2 day
the growth in infarct volume (mL)
24 hour DWI infarct volume (mL) - 7 day FLAIR infarct volume (mL)
Time frame: from 24 hour to 7 day
the penumbral salvage volume (mL)
baseline CTP hypoperfusion volume (mL) - 24 hour DWI infarct volume (mL)
Time frame: from baseline to 1 day
the change on the NIHSS score
baseline NIHSS score - 1 day NIHSS score
Time frame: from baseline to 1 day
the change on the NIHSS score
baseline NIHSS score - 7 day NIHSS score baseline NIHSS score - 7 day NIHSS score baseline NIHSS score - 7 day NIHSS score
Time frame: from baseline to 7 day
the change on the EQ-5D score
baseline EQ-5D score - 90 day EQ-5D score
Time frame: from baseline to 90 day
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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The Affiliated Hospital of Xuzhou Medical University