Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke

Study Overview
=================
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.

Official Title
-----------------
Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke: An Open-label, Blinded Endpoint, Randomized Controlled Trial

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: Aspirin
* Drug: Clopidogrel
* Drug: Alteplase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 40-80 years. Diagnosed with acute ischemic stroke, NIHSS ≤ 5 and single item score ≤ 1 for vision, language, single limb, and no impairment of consciousness. Time from symptoms onset to randomization within 4.5 hours; the onset time refers to the Last Known Normal (LKN). Absence of large vessel occlusion on CTA. Pre-stroke mRS ≤ 1. Signed informed consent. Exclusion Criteria: Clinically confirmed valvular or non-valvular atrial fibrillation requiring anticoagulation therapy. Intracranial hemorrhage or subarachnoid hemorrhage suggested by CT scan. Acute coronary syndrome suggested by Electrocardiogram. History of gastrointestinal bleeding. Planned sequential IVT or endovascular treatment. History of allergy to aspirin, clopidogrel, and/or alteplase. Systolic blood pressure exceeding 185 mmHg and/or diastolic blood pressure exceeding 110 mmHg despite antihypertensive treatment. Blood glucose ≤ 2.7 mmol/L. Epileptic seizures during a stroke attack. Recent trauma (<15 days). Recent intracranial or spinal cord surgery, head trauma, or stroke (<3 months). History of intracranial hemorrhage, aneurysm, vascular malformation, or brain tumor. Active visceral hemorrhage (<22 days). History of anticoagulant use within 24 hours prior to onset. Platelets <100,000, PTT > 40 seconds on heparin, or PT > 15 or INR > 1.7, or known bleeding disposition. Anticipated life expectancy < 3 months. Pregnant or lactating women. Participation in other clinical trials. 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).

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAPT group<br>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. | Drug: Aspirin<br>* See arm/group descriptions.<br>Drug: Clopidogrel<br>* See arm/group descriptions.<br>|
| Active Comparator: IVT group<br>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. | Drug: Alteplase<br>* See arm/group descriptions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |