Compares aspirin with clopidogrel against alteplase for acute minor ischemic stroke
Compares aspirin with clopidogrel versus alteplase in people with acute minor ischemic stroke.
Plain-language title generated from the registry record
Registry title: Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
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?
Source: NCT05910125, who can take part
Where in China
- Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Trial code
- NCT05910125
- Record updated
- 18 June 2023
- Original description
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.Read full original descriptionShow less
Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke: An Open-label, Blinded Endpoint, Randomized Controlled Trial
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.
Inclusion: 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: 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.