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An open-label, blinded endpoint, randomized controlled trial that includes patients diagnosed with non-disabling, non-large vessel occlusion, acute minor stroke within 4.5 hours of onset. Eligible participants would be randomly assigned to the thrombolysis group (intravenous alteplase) and the dual antiplatelet group (oral aspirin plus clopidogrel). The primary outcome is the proportion of the excellent functional outcome (modified Rankin scale 0-1) at 90 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAPT group | Experimental | Receiving dual antiplatelet therapy immediately after randomization (Oral aspirin 100mg+clopidogrel 300mg, Day 1). Participants who show no evidence of intracranial hemorrhage on skull CT 24 hours after randomization will receive oral aspirin 100mg/d (Day 2-90) and clopidogrel 75mg/d (Day 2-21), while those with intracranial hemorrhage on skull CT will not receive any antiplatelet drugs. |
|
| IVT group | Active Comparator | Receiving intravenous thrombolysis immediately after randomization (Intravenous alteplase, 0.9mg/kg, a maximum dosage of 90mg). Participants who show no evidence of intracranial hemorrhage on skull CT 24 hours after randomization will receive oral aspirin 100mg/d (Day 2-90), while those with intracranial hemorrhage on skull CT will not receive any antiplatelet drugs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | See arm/group descriptions. |
| |
| Clopidogrel |
| Measure | Description | Time Frame |
|---|---|---|
| The modified Rankin Scale score (mRS) 0-1 | The proportion of the modified Rankin Scale score (mRS) 0-1 at 90 days. | 90(±7) days |
| Measure | Description | Time Frame |
|---|---|---|
| The modified Rankin Scale score (mRS) 0-1 | The proportion of the modified Rankin Scale score (mRS) 0-1 at 7 days or discharge (whichever occurred first). | 7(±1) days |
| Early neurological deterioration |
| Measure | Description | Time Frame |
|---|---|---|
| SAFETY OUTCOME: Symptomatic intracranial hemorrhage | Symptomatic intracranial hemorrhage within 36 hours (according to Heidelberg criteria) | 24 (±12) hours |
| SAFETY OUTCOME: Mortality | Mortality at 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yamei Tang | Contact | 86-20-81332619 | tangym@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yamei Tang | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | 510120 | 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 |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Drug |
See arm/group descriptions. |
|
| Alteplase | Drug | See arm/group descriptions. |
|
The incidence of early neurological deterioration at 7 days.
| 7(±1) days |
| Recurrent stroke | The incidence of recurrent stroke at 90 days. | 90(±7) days |
| 90(±7) days |
| SAFETY OUTCOME: Any intracranial hemorrhage | Any intracranial hemorrhage within 36 hours (according to Heidelberg criteria) | 24 (±12) hours |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012697 | Serine Endopeptidases |
| 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 |