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The purpose of this study is to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT
Nearly half of acute ischemic stroke patients underwent intravenous thrombolysis (IVT) failed to achieve excellent functional outcome. Some studies reported that early administrated tirofiban, a selective glycoproteinⅡb/Ⅲa receptor inhibitor, may greatly improve the outcome of patients who received IVT, however they only recruited small sample size.
Thus, the investigators design early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT) trial, aiming to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirofiban group | Active Comparator | Tirofiban infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT |
|
| Tirofiban simulant group | Placebo Comparator | Tirofiban simulant infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirofiban | Drug | Tirofiban is a selective glycoproteinⅡb/Ⅲa receptor inhibitor, which inhibits platelet aggregation and thrombi formation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients of modified Rankin Scale (mRS)≤1 | mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-1 represents excellent functional outcome | 90±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients of mRS≤2 | mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-2 represents favorable functional outcome | 90±7 days |
| Distribution of mRS | mRS depicts functional outcome of stroke, which ranges from 0-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic intracranial hemorrhage | Symptomatic intracranial hemorrhage is defined according to the ECASS Classification | within 24 hours of completion of study drug infusion, hospitalization |
| Hemorrhagic transformation |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first hospital of Jilin University | Recruiting | Changchun | Jilin | 130000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38196129 | Derived | Guo ZN, Zhang KJ, Zhang P, Qu Y, Abuduxukuer R, Nguyen TN, Chen HS, Yang Y. Early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT): Study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial. Eur Stroke J. 2024 Jun;9(2):510-514. doi: 10.1177/23969873231225069. Epub 2024 Jan 9. |
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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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| Tirofiban simulant | Drug | Tirofiban simulant is placebo packed the same style as tirofiban |
|
| 90±7 days |
| National Institute of Health stroke scale (NIHSS) | National Institute of Health stroke scale (NIHSS) ranges from 0 to 42, a low value represents a better outcome | 24 hours after IVT, 7 days |
defined according to the ECASS Classification
| 24 hours after IVT, hospitalization |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |