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This randomized controlled trial aims to evaluate whether adjunctive tirofiban therapy combined with endovascular treatment (EVT) improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. Patients will be randomized to receive either tirofiban or matching placebo after EVT. The primary efficacy endpoint is the proportion of patients achieving functional independence (modified Rankin Scale 0-2) at 90±7 days, while the safety endpoint is the probability of symptomatic intracranial hemorrhagewithin 48 hours after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirofiban group | Experimental | Receive Tirofiban treatment following endovascular therapy |
|
| placebo group | Placebo Comparator | Receive placebo treatment after endovascular therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirofiban | Drug | After endovascular treatment, tirofiban is infused at a rate of 0.4 μg/kg/min for 30 minutes, followed by a maintenance infusion at 0.1 μg/kg/min until 24 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with mRS 0-2 | Proportion of patients with Modified Rankin Scale (mRS) 0-2, Modified Rankin Scale(0-6), A lower MRS score indicates better functional status for the patient. | 90±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NIHSS score from baseline | Change in National Institute of Health stroke scale score from baseline.The NIH Stroke Scale (NIHSS) score ranges from 0 to 42 points, with lower scores indicating better neurological function | 36±12 hours post-randomization |
| Vascular recanalization rate assessed by CT/MR angiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaochuan Huo, Doctor | Contact | +86 13716292262 | hxc810909@163.com | |
| Xin Tong, Doctor | Contact | +86 17810651085 | tomice123@foxmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital Affiliated to Capital Medical University | Recruiting | Beijing | Beijing Municipality | 101118 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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| Placebo | Drug | Following endovascular treatment, patients receive normal saline placebo, with the dosage calculated in the same manner as that of tirofiban in the experimental group. |
|
Vascular recanalization rate assessed by CT/MR angiography |
| 36±12 hours post-randomization |
| Change in infarct volume | Change in infarct volume | 7±3 days post-randomization or discharge |
| Distribution of mRS scores | Modified Rankin Scale(0-6), A lower MRS score indicates better functional status for the patient. | 7±3 days/discharge;90±7 days post-randomization |
| Proportion of patients achieving mRS 0-1 | Proportion of patients achieving mRS 0-1 | 90±7 days |
| Proportion of patients achieving mRS 0-3 | Proportion of patients achieving mRS 0-3 | 90±7 days |
| Incidence of Pharmacologic rescue therapy | Incidence of Pharmacologic rescue therapy | 90±7 days |
| Incidence of rescue therapy | Incidence of rescue therapy | 90±7 days |
| EQ-5D-5L utility score | The EuroQol 5-Dimension 5-Level Utility Score (EQ-5D-5L utility score) ranges from -0.594 to 1.000 (Chinese value set), assessing health-related quality of life, with higher scores indicating better health status. | 90±7 days |
| Probability of symptomatic intracranial hemorrhage | Probability of symptomatic intracranial hemorrhage (Heidelberg Standards) | 48 hours |
| All-cause mortality | All-cause mortality | 90±7 days post-randomization |
| Probability of any intracranial hemorrhage | Probability of any intracranial hemorrhage (Heidelberg Standards) | 48 hours post-randomization |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |