Ischemic Stroke
Conditions
Brief summary
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.
Interventions
DRUGAspirin
See arm/group descriptions.
DRUGClopidogrel
See arm/group descriptions.
DRUGAlteplase
See arm/group descriptions.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 40-80 years. 2. Diagnosed with acute ischemic stroke, NIHSS ≤ 5 and single item score ≤ 1 for vision, language, single limb, and no impairment of consciousness. 3. Time from symptoms onset to randomization within 4.5 hours; the onset time refers to the Last Known Normal (LKN). 4. Absence of large vessel occlusion on CTA. 5. Pre-stroke mRS ≤ 1. 6. Signed informed consent.
Exclusion criteria
1. Clinically confirmed valvular or non-valvular atrial fibrillation requiring anticoagulation therapy. 2. Intracranial hemorrhage or subarachnoid hemorrhage suggested by CT scan. 3. Acute coronary syndrome suggested by Electrocardiogram. 4. History of gastrointestinal bleeding. 5. Planned sequential IVT or endovascular treatment. 6. History of allergy to aspirin, clopidogrel, and/or alteplase. 7. Systolic blood pressure exceeding 185 mmHg and/or diastolic blood pressure exceeding 110 mmHg despite antihypertensive treatment. 8. Blood glucose ≤ 2.7 mmol/L. 9. Epileptic seizures during a stroke attack. 10. Recent trauma (\<15 days). 11. Recent intracranial or spinal cord surgery, head trauma, or stroke (\<3 months). 12. History of intracranial hemorrhage, aneurysm, vascular malformation, or brain tumor. 13. Active visceral hemorrhage (\<22 days). 14. History of anticoagulant use within 24 hours prior to onset. 15. Platelets \<100,000, PTT \> 40 seconds on heparin, or PT \> 15 or INR \> 1.7, or known bleeding disposition. 16. Anticipated life expectancy \< 3 months. 17. Pregnant or lactating women. 18. Participation in other clinical trials. 19. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The modified Rankin Scale score (mRS) 0-1 | 90(±7) days | The proportion of the modified Rankin Scale score (mRS) 0-1 at 90 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The modified Rankin Scale score (mRS) 0-1 | 7(±1) days | The proportion of the modified Rankin Scale score (mRS) 0-1 at 7 days or discharge (whichever occurred first). |
| Early neurological deterioration | 7(±1) days | The incidence of early neurological deterioration at 7 days. |
| Recurrent stroke | 90(±7) days | The incidence of recurrent stroke at 90 days. |
Other
| Measure | Time frame | Description |
|---|---|---|
| SAFETY OUTCOME: Any intracranial hemorrhage | 24 (±12) hours | Any intracranial hemorrhage within 36 hours (according to Heidelberg criteria) |
| SAFETY OUTCOME: Symptomatic intracranial hemorrhage | 24 (±12) hours | Symptomatic intracranial hemorrhage within 36 hours (according to Heidelberg criteria) |
| SAFETY OUTCOME: Mortality | 90(±7) days | Mortality at 90 days |
Countries
China
Contacts
Primary ContactYamei Tang
Outcome results
None listed