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Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend intravenous thrombolysis as the first treatment of ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurological prognosis of thrombolytic patients has been a hot topic in the world.
Recent studies have found that the combined application of argatroban and rt-PA in the treatment of AIS might improve the clinical prognosis and not significantly increase bleeding. Some studies have reported that the combined application of argatroban and rt-PA could improve the blood vessel opening rate, and prevent re-occlusion after opening.
Based on the discussion, the present study is designed to explore the efficacy and safety of argatroban plus rt-PA in the treatment of AIS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Argatroban combined with rt-PA | Experimental | Drug: Argatroban combined with rt-PA Argatroban as a 100 ug/kg bolus over 3 to 5 minutes was administered intravenously within 1 hour of the tPA bolus followed by a continuous Argatroban infusion of 1.0 ug/kg per minute for 48 hours adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%) |
|
| rt-PA | Active Comparator | Drug: rt-PA Intravenous throbolysis with 0.9mg/kg rtPA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rt-PA | Drug | Intravenous throbolysis with 0.9mg/kg rtPA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of mRS (0-1) | 90±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of mRS (0-2) | 90±7 days | |
| proportion of more than 2 decrease in NIHSS score | NIHSS, National Institute of Health stroke scale | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huisheng Chen, Doctor | Neurology Department | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of ShenYang Military Region | Shenyang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41678142 | Derived | Chen MR, Liu F, Nguyen TN, Chen HS. Circadian Rhythm and Efficacy of Argatroban in Ischemic Stroke with Alteplase: A Post Hoc Analysis of the ARAIS Trial. CNS Drugs. 2026 May;40(5):687-695. doi: 10.1007/s40263-026-01270-3. Epub 2026 Feb 12. | |
| 40635702 | Derived | Cui Y, Wang EQ, Wang YH, Chen HS. Efficacy of argatroban plus alteplase according to time from onset to thrombolysis in acute ischemic stroke: a prespecified post-hoc analysis of the ARAIS trial. Front Neurol. 2025 Jun 25;16:1582513. doi: 10.3389/fneur.2025.1582513. eCollection 2025. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C031942 | argatroban |
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| Argatroban | Drug | 100 ug/kg bolus over 3 to 5 minutes was administered intravenously, followed by a continuous Argatroban infusion of 1.0 ug/kg per minute for 48 hours adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%) |
|
| proportion of early neurological deterioration | Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score | 48 hours |
| Vascular Events | The occurence of stroke or other vascular events | 90±7 days |
| symptomatic intracranial hemorrhage | 48 hours |
| 36757755 | Derived | Chen HS, Cui Y, Zhou ZH, Dai YJ, Li GH, Peng ZL, Zhang Y, Liu XD, Yuan ZM, Jiang CH, Yang QC, Duan YJ, Ma GB, Zhao LW, Wang RX, Sun YL, Shen L, Wang EQ, Wang LH, Feng YF, Wang FY, Zou RL, Yang HP, Wang K, Wang DL, Wang YL; ARAIS Investigators. Effect of Argatroban Plus Intravenous Alteplase vs Intravenous Alteplase Alone on Neurologic Function in Patients With Acute Ischemic Stroke: The ARAIS Randomized Clinical Trial. JAMA. 2023 Feb 28;329(8):640-650. doi: 10.1001/jama.2023.0550. |
| 32485328 | Derived | Yang Y, Zhou Z, Pan Y, Chen H, Wang Y; ARAIS Protocol Steering Group. Randomized trial of argatroban plus recombinant tissue-type plasminogen activator for acute ischemic stroke (ARAIS): Rationale and design. Am Heart J. 2020 Jul;225:38-43. doi: 10.1016/j.ahj.2020.04.003. Epub 2020 Apr 8. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |