Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fingolimod with standard therapy | Experimental | Patients will be treated with intravascular therapy and fingomod. |
|
| Placebo with standard therapy | Placebo Comparator | Patients will be treated with intravascular therapy and placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingolimod | Drug | fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 90 day mRS score | recovery | at day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| mRS score of 0-1 (%) | excellent recovery | at day 90 |
| mRS score of 1-2 (%) | general recovery | at day 90 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ye Xinchun | Contact | +8615996999283 | lzh316@vip.qq.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | placebo once daily, for three consecutive days, |
|
| Recanalization success rate | baseline mTICI score - 2 day mTICIS score | from baseline to 2 day |
| the growth in infarct volume (mL) | 24 hour DWI infarct volume (mL) - 7 day FLAIR infarct volume (mL) | from 24 hour to 7 day |
| the penumbral salvage volume (mL) | baseline CTP hypoperfusion volume (mL) - 24 hour DWI infarct volume (mL) | from baseline to 1 day |
| the change on the NIHSS score | baseline NIHSS score - 1 day NIHSS score | 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 | from baseline to 7 day |
| the change on the EQ-5D score | baseline EQ-5D score - 90 day EQ-5D score | from baseline to 90 day |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |