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Not yet taking people in ChinaPhase 4

Compares aspirin with clopidogrel against alteplase for acute minor ischemic stroke

Compares aspirin with clopidogrel versus alteplase in people with acute minor ischemic stroke.

Key facts

Who runs it
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Where
Guangzhou, ChinaSee the site
Trial code
Registry title
Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke
Status
Not yet recruiting
Phase
Phase 4
People taking part
472 people, planned
Started
Jul 2023
Expected to end
Jul 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Aspirin
  • Clopidogrel
  • Alteplase
Record updated
18 June 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40-80 who have had a minor ischemic stroke within the last 4.5 hours, with no blocked large blood vessel. It compares alteplase with aspirin plus clopidogrel.

Age
40-80 years
Sex
All sexes can join.
Disease stage
Acute ischemic stroke with NIHSS ≤ 5 and a single-item score ≤ 1 for vision, language and single limb. No impairment of consciousness. No large vessel occlusion on CTA. Pre-stroke mRS ≤ 1.
Earlier treatment
No anticoagulant use within 24 hours before onset. No planned follow-on IVT or endovascular treatment.

Main reasons for not taking part

  • Atrial fibrillation that needs anticoagulation therapy
  • Bleeding in the brain, or history of gastrointestinal bleeding
  • Allergy to aspirin, clopidogrel or alteplase
  • Blood pressure above 185/110 mmHg despite treatment
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Clinically confirmed valvular or non-valvular atrial fibrillation requiring anticoagulation therapy
  • History of anticoagulant use within 24 hours prior to onset
  • Intracranial hemorrhage or subarachnoid hemorrhage suggested by CT scan
  • Acute coronary syndrome suggested by Electrocardiogram
  • History of gastrointestinal bleeding
  • History of allergy to aspirin, clopidogrel, and/or alteplase
  • Epileptic seizures during a stroke attack
  • 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)
  • 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)
  • Blood glucose ≤ 2.7 mmol/L
  • Platelets <100,000, PTT > 40 seconds on heparin, or PT > 15 or INR > 1.7, or known bleeding disposition
  • Planned sequential IVT or endovascular treatment
  • Systolic blood pressure exceeding 185 mmHg and/or diastolic blood pressure exceeding 110 mmHg despite antihypertensive treatment
  • Recent trauma (<15 days)
  • Anticipated life expectancy < 3 months
  • Pregnant or lactating women
  • Participation in other clinical trials

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 80 years old?

Where in China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, ChinaContact: Yamei TangNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • DAPT groupTreatment being tested

    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.

    Treatment: Aspirin and Clopidogrel

  • IVT groupExisting treatment, for comparison

    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.

    Treatment: Alteplase

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke: An Open-label, Blinded Endpoint, Randomized Controlled Trial
Plain-language title
Compares aspirin with clopidogrel against alteplase for acute minor ischemic strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05910125, who can take part
Record updated
18 June 2023