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Thrombolysis and endovascular thrombectomy are the most efficient treatments for acute ischemic stroke patients in time window. Although sufficient recanalization after thrombectomy is more than 80%, HERMES study indicated that nearly half of the ischemic stroke patients under thrombectomy suffered obvious disability. Artery reocclusion, hemorrhagic transformation, and no-reflow phenomenon are among the most important reasons of poor prognosis of acute ischemic stroke patients. The investigators speculate that a combination of argatroban, edaravone, and glucocorticoid may be helpful in preventing artery reocclusion, hemorrhagic transformation, and no-reflow phenomenon. This study intends to explore the safety, feasibility and efficacy of thrombectomy with sufficient recanalization bridged by intra-arterial cocktail therapy in acute ischemic stroke patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intra-arterial cocktail therapy | Experimental | Intra-arterial administration of argatroban (0.2-0.3 mg/min), dexamethasone (0.1 mg/min) and edaravone (0.3 mg/min) for 30 to 60 minutes after thrombectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intra-arterial cocktail therapy | Drug | Intra-arterial administration of argatroban (0.2-0.3 mg/min), dexamethasone (0.1 mg/min) and edaravone (0.3 mg/min) for 30 to 60 minutes after thrombectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of favorable outcome | favorable outcome is defined as mRS 0-2 | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of excellent outcome | excellent outcome is defined as mRS 0-1 | 90 days |
| proportion of early neurological improvement | early neurological improvement is defined as more than 4 decrease in NIHSS |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of symptomatic intracranial haemorrhage | intracranial haemorrhage is defined as more than 4 increase in NIHSS caused by intracranial bleeding | 48 hours |
Inclusion Criteria:
Exclusion Criteria:
4. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia ( <100000/mm3).
5. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis.
6. Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg).
7. Patients with contraindication or allergic to any ingredient of drugs in our study.
8. Unsuitable for this clinical studies assessed by researcher.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Northern Theater Command | Shenyang | 110840 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39711792 | Derived | Zhao ZA, Hu HZ, Li W, Qiu J, Zhao YG, Nguyen TN, Chen HS. Intra-arterial cocktail therapy for patients with anterior circulation large vessel occlusion who achieved endovascular reperfusion. Front Neurol. 2024 Dec 6;15:1450156. doi: 10.3389/fneur.2024.1450156. eCollection 2024. |
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| 48 hours |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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