Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke

• Status: Not yet recruiting
• Trial end date: 2027-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Treatments: Aspirin; Clopidogrel; Tissue Plasminogen Activator

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).