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Not yet recruiting NCT05910125

Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke

Phase IV Interventional Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspirin, Clopidogrel, Alteplase.
Who it may be relevant to
Registry conditions: Ischemic Stroke. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Aspirin
    See arm/group descriptions.
  • Drug Clopidogrel
    See arm/group descriptions.
  • Drug Alteplase
    See arm/group descriptions.

Primary outcome measures

  • The modified Rankin Scale score (mRS) 0-1 [Time frame: 90(±7) days]
Secondary outcome measures (3)
  • The modified Rankin Scale score (mRS) 0-1 [Time frame: 7(±1) days]
  • Early neurological deterioration [Time frame: 7(±1) days]
  • Recurrent stroke [Time frame: 90(±7) days]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou

Identifiers

NCT: NCT05910125 · SYSKY-2022-252-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗