Clinical trial NCT05910125: Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke
Official title: Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke: An Open-label, Blinded Endpoint, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Ischemic Stroke
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 472
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: The modified Rankin Scale score (mRS) 0-1
timeFrame: 90(±7) days
Secondary outcomes:
measure: The modified Rankin Scale score (mRS) 0-1
timeFrame: 7(±1) days
measure: Early neurological deterioration
timeFrame: 7(±1) days
measure: Recurrent stroke
timeFrame: 90(±7) days
Other outcomes:
measure: SAFETY OUTCOME: Symptomatic intracranial hemorrhage
timeFrame: 24 (±12) hours
measure: SAFETY OUTCOME: Mortality
timeFrame: 90(±7) days
measure: SAFETY OUTCOME: Any intracranial hemorrhage
timeFrame: 24 (±12) hours
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Yamei Tang
role: PRINCIPAL_INVESTIGATOR
References: