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Intravenous (IV) Alteplase (rt-PA) is the gold standard for brain infarction within 4 h 30 of symptoms onset. Efficacy of this therapy is limited in the setting of large artery occlusions. For middle cerebral artery occlusions (MCA)or internal carotid artery occlusions (ICA), recanalization rates will drop as low as 10%. This element is critical as prognosis is linked to recanalization. Arterial re-occlusions are frequent and may reach 30%, which limits IV thrombolysis efficacy.With the endovascular approach, recanalization rates may reach 90% with last generation devices. A recent meta-analysis has shown that the best candidates for thrombectomy are MCA occlusions. In the coronary literature, endovascular therapy efficacy is increased in association with antiplatelets such as abciximab. The aim of the study was to assess the feasibility of thrombectomy associated with abciximab on revascularisation (TICI score), as well as safety (symptomatic intracranial bleeding), in order to design a clinical trial versus the gold standard for acute ischemic stroke revascularization strategies using IV rt-PA.This is a controlled, pilot study, evaluating feasibility and safety of thrombectomy with abciximab versus IV rt-PA in acute ischemic stroke patients within 4h30 of symptoms onset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abciximab IV and thrombectomy | Experimental | abciximab IV (0.25mg/kg by IV bolus, following by 0.125μg/kg by 12 hours IV drip) and thrombectomy |
|
| alteplase | Active Comparator | alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abciximab IV and thrombectomy | Procedure |
| ||
| alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip) |
| Measure | Description | Time Frame |
|---|---|---|
| recanalization rate | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic intracranial bleeding | 24 hours | |
| percentage of patients with a favorable outcome | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stroke Center, Bichat Hospital | Paris | 78018 | France |
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| ID | Term |
|---|---|
| D020244 | Infarction, Middle Cerebral Artery |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
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| ID | Term |
|---|---|
| D017131 | Thrombectomy |
| D010959 | Tissue Plasminogen Activator |
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D012697 | Serine Endopeptidases |
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| Drug |
|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |