NCT05910125Not yet recruitingPhase 4
Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke
Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke: An Open-label, Blinded Endpoint, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 18 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 472 (estimated)
- First submitted
- 11 Jun 2023
- Start date
- Jul 2023
- Primary completion date
- Jul 2027
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Stroke
- NCT number
- NCT05910125
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 472
- From Jul 2023 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically confirmed valvular or non-valvular atrial fibrillation requiring anticoagulation therapy.
- History of anticoagulant use within 24 hours prior to onset.
Other illness
- 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).
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.